Proposal for a Directive of the European Parliament and of the Council on machinery and amending Directive 95/16/EC
Date: 2001-01-26
Institutions: European Commission
Subjects: EU trade mark, machine-tool industry, machinery, marketing, occupational health, product safety, safety standard

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Proposal for a Directive of the European Parliament and of the Council on machinery and
amending Directive 95/16/EC

(2001/C 154 E/15)

(Text with EEA relevance)

COM(2000) 899 final (cid:151) 2001/0004(COD)

(Submitted by the Commission on 26 January 2001)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

potentially explosive atmospheres (3), roll-over protection
structures and falling-object protective structures, which
are covered by the declaration of the manufacturer of
the complete machinery and logic units which ensure
the safety functions of bimanual controls, which are
now an integral part of
the machinery placed on the
market.

Having regard to the opinion of
Committee,

the Economic and Social

(5) In order to ensure legal certainty for users, the scope of
this Directive and the concepts relating to its application
should be defined as precisely as possible.

Acting in accordance with the procedure laid down in Article
251 of the Treaty,

Whereas:

(1) Directive 98/37/EC of the European Parliament and of the
Council of 22 June 1998 on the approximation of the
relating to machinery (1)
laws of
codified Directive 89/392/EEC (2). Since further substantial
amendments are to be made to Directive 98/37/EC,
it
should be recast in the interests of clarity.

the Member States

(2) The machinery sector is an important part of the engin-
eering industry and is one of the industrial mainstays of
the Community economy. The social cost of the large
number of accidents caused directly by the use of
machinery can be reduced by inherently safe design and
construction of machinery and by proper installation and
maintenance.

(3) Member States are responsible for ensuring the health and
in particular of
territory of persons,
safety on their
workers and consumers and, where appropriate, of
domestic animals and goods, notably in relation to the
risks arising out of the use of machinery.

(4) The maintenance or improvement of the level of safety
attained in the Member States constitutes one of
the
essential aims of
this Directive. However, unnecessary
constraints imposed on undertakings for certain types of
machinery should be reduced: machines for the manu-
facture of pyrotechnics,
the main hazard of which is
covered by Directive 94/9/EC of the European Parliament
and of the Council of 23 March 1994 on the approxi-
mation of
the Member States concerning
equipment and protective systems intended for use in

the laws of

(6) The mandatory provisions governing construction site
hoists intended for lifting persons or persons and goods
intended for
and portable cartridge-operated devices
industrial or technical use, which are often supplemented
by de facto compulsory technical specifications and/or by
voluntary standards, do not necessarily lead to different
levels of health and safety but, because of their disparities,
do nevertheless constitute barriers to trade within the
the
Community. Moreover,
conformity
these
and
assessment
is therefore desirable
machines diverge considerably.
not
intended for
lifting persons or persons and goods, and portable
cartridge-operated fixing devices, from the scope of this
Directive, since the latter are excluded from the scope of
Council Directive 91/477/EEC of 18 June 1991 on control
of the acquisition and possession of weapons (4).

to exclude construction site hoists

certification
It

the national

systems

for

of

(7) Construction site hoists intended for lifting persons or
persons and goods, which are but one specific example
of devices for lifting persons, should be covered by this
Directive. However, the health and safety requirements
their
laid down by this Directive cannot,
specific use, apply to theatre elevators,
is to say
devices for lifting persons which are permanently or
temporarily installed in auditoria and which permit the
movement of persons from the stage to adjacent locations
and vice versa.

in view of
that

(8) Market surveillance is an essential instrument inasmuch as
it ensures the proper and uniform application of
the
provisions of Directives.
is therefore appropriate to
It
put in place the legal framework within which it can
proceed harmoniously.

(1) OJ L 207, 23.7.1998, p. 1, Directive amended by Directive 98/79/EC

(OJ L 331, 7.12.1998, p. 1).
(2) OJ L 183, 29.6.1989, p. 9.

(3) OJ L 100, 19.4.1994, p. 1.
(4) OJ L 256, 13.9.1991, p. 51.

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(9) In the context of

surveillance, a clear
this market
distinction should be established between the disputing
of a harmonised standard conferring a presumption of
conformity on machinery and the
safeguard clause
relating to machinery.

use of the CE conformity marking, which are intended to
be used in the technical harmonisation directives (1) and
takes account of the nature of the verification required for
such machinery.

this Directive can relate only to the use of

(10) The putting into service of machinery within the meaning
of
the
for a
machinery itself
purpose which can reasonably be foreseen. This does
not preclude the laying down of conditions of use
external
is not
to the machinery, provided that
thereby modified in a way not specified in this Directive.

intended purpose or

for

its

it

(11) Where the machinery may be used by a consumer, that is
the manufacturer
to say a non-professional operator,
should take account of
in the manufacturing
process. The same will apply where a machine is used
normally to provide a service to a consumer.

this

(12) Although the body of provisions of this Directive may not
it is nevertheless
apply to partly completed machinery,
important
free movement be guaranteed
their
where they are specifically stated to be intended for incor-
poration into or assembled with other machinery to form
a machine covered by this Directive.

that

(13) For trade fairs, exhibitions, etc.,

it must be possible to
exhibit machinery which does not satisfy the requirements
of this Directive. However,
interested parties should be
properly informed that the machinery does not conform
and cannot be purchased in that condition.

for

specific

requirements

(14) This Directive defines only the essential health and safety
requirements of general application, supplemented by a
number of more
certain
categories of machinery. In order to help manufacturers
to prove conformity to these essential requirements, and
to allow inspection of
essential
it is desirable to have standards that are
requirements,
harmonised at Community level
for the prevention of
risks arising out of
the design and construction of
machinery. These standards harmonised at Community
level are drawn up by private-law bodies and must
retain their non-binding status.

conformity to the

(15) In view of the nature of the risks involved in the use of
for
machinery covered by this Directive, procedures
assessing conformity to the essential health and safety
should be established. These procedures
requirements
should be devised in the light of
the
danger inherent in such machinery. Consequently, each
category of machinery should have
its appropriate
procedure, which is
in conformity with Council
Decision 93/465/EEC of 22 July 1993 concerning the
modules
the conformity
assessment procedures and the rules for the affixing and

the various phases of

the extent of

for

(16) Manufacturers

should

retain full

responsibility
for
their machinery to the
certifying the conformity of
provisions of
for certain
types of machinery having a higher risk factor, a stricter
certification procedure is desirable.

this Directive. Nevertheless,

(17) The CE marking should be fully recognised as being the
only marking which guarantees
the machinery
conforms to the requirements of this Directive. All other
markings which are liable to mislead third parties as to
the meaning or the form of the CE marking should be
prohibited.

that

(18) In order to ensure the same quality for the CE marking
and the manufacturer’s mark, it is important that they be
affixed according to the same techniques.
In order to
avoid confusion between any CE markings which might
appear on certain components and the CE marking corre-
sponding to the machinery, it is important that the latter
marking be affixed alongside the name of the person who
has taken responsibility for it, namely the manufacturer or
his authorised representative.

(19) The manufacturer or his authorised representative should
also be obliged to carry out a risk analysis for the
machinery which he wishes to place on the market. For
this purpose, he should determine which are the essential
to his
health
requirements
machinery and in respect of which he must
take
measures.

applicable

safety

and

(20) It is essential that, before drawing up the EC declaration of
conformity, the manufacturer or his authorised represen-
tative established in the Community, should prepare a
it is not essential
technical construction file. However,
that all documentation should be physically produced,
but it must be possible to make it available on request.
It need not include detailed plans of subassemblies used
for the manufacture of machinery, unless knowledge of
in order to ascertain conformity
such plans is essential
with the essential health and safety requirements.

(21) The addressees of any decision taken under this Directive
should be informed of the reasons for such a decision and
of the legal remedies open to them.

for

the exercise of

(22) In accordance with Article 2 of Council Decision
1999/468/EC of 28 June 1999 laying down the
implementing powers
procedures
conferred on the Commission (2), measures
the
implementation of this Directive should be adopted by
use of the advisory procedure provided for in Article 3
of that Decision or by use of the regulatory procedure
provided for in Article 5 of that Decision, as appropriate.

for

(1) OJ L 220, 30.8.1993, p. 23.
(2) OJ L 184, 17.7.1999, p. 23.

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(23) Member States should provide for penalties applicable to
infringements of
this Directive. The
penalties should be effective, proportionate and dissuasive.

the provision of

(f) mobile offshore units and machinery covered by this

Directive installed on board such units;

(g) machines specially designed and constructed for military

(24) The application of this Directive to a number of machines
intended for lifting persons, particularly persons with
limited mobility,
is conducive to a better definition of
the products covered by this Directive in relation to
Directive 95/16/EC of the European Parliament and of
the Council of 29 June 1995 on the approximation of
the laws of the Member States relating to lifts (1). A rede-
that Directive was deemed
finition of
necessary
amended
accordingly.

the scope of
and

the Directive

should

be

(25) In accordance with the principle of proportionality, it is
the
necessary and appropriate,
fundamental objection of
safety of
machinery put on the market, to lay down the essential
health and safety requirements in relation to its design
and manufacture. The Directive confines itself
to the
minimum required in order to achieve those objectives,
in accordance with Article 5 of the Treaty,

in order to implement
improving

the

or police purposes;

(h) mine winding gear;

(i)

theatre elevators for persons;

(j)

products falling into the following areas:

(i) household appliances,

(ii) audio and video equipment,

(iii) information technology equipment,

(iv) office machinery and equipment,

(v) circuit-breakers and switches;

HAVE ADOPTED THIS DIRECTIVE:

(k)

the following types of high-voltage electrical equipment:

Article 1

Scope

1.

This Directive applies to:

(i) switch gear and control gear,

(ii) transformers;

(l) motors of all types;

(a) the products defined in points (a)

to (i) of

the second

paragraph of Article 2;

(m) industrial sites taken as a whole, such as petrochemical

plants or heat or power stations;

(b) vehicles designed and built to carry out work other than
just the transport of persons and used in airports and in the
mineral extraction industry.

(n) medical devices.

The following are excluded from the scope of

2.
Directive:

this

Article 2

Definitions

(a)

spare parts

components, including safety components, or equipment,
including interchangeable equipment, intended to be used
as
components or
equipment supplied by the manufacturer of the original
machinery or by a third party in accordance with the
manufacturer’s instructions;

to replace

identical

(b)

specific equipment for use in fairgrounds and amusement
parks;

(c) machinery specially designed or put

nuclear purposes which,
result in an emission of radioactivity;

in the event of

into service for
failure, may

For the purposes of
(cid:145)machinery(cid:146) means the
this Directive,
products defined in points (a) to (h) of this Article, and the
vehicles referred to in point (b) of Article 1(1).

The following definitions shall apply:

(a)

(cid:145)machinery stricto sensu(cid:146)

(i) an assembly, fitted with or intended to be fitted with a
drive system other than directly applied manual or
consisting
animal
or
effort,
least one of which moves, and
components, at
which are joined together for a specific application,

linked

parts

of

(d)

firearms;

(e) means of transport, including trailers;

(1) OJ L 213, 7.9.1995, p. 1.

(ii) machinery referred to in (i), missing only the
components to connect it on site or to sources of
energy and motion,

(iii) machinery referred to in (i), ready to be installed and
able to function as it stands only if mounted on a
vehicle or installed in a building or a structure,

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(iv) lifting apparatus whose only power source is directly

applied manual effort;

self-propelled machine or a tractor and another machine
by joining them at the first fixed bearing. At least one of
these two machines must be mobile;

(b)

(c)

(cid:145)assembly of machinery(cid:146) means an assembly of machinery
and/or of partly completed machinery which, in order to
achieve the same end, are arranged and controlled so that
they function as an integral whole;

(cid:145)interchangeable equipment(cid:146) means a device which, after
the placing into service of machinery or of a tractor, is
assembled with that machinery or tractor by the operator
himself in order to change its function or attribute a new
function in so far as this equipment is not a spare part or
a tool;

(g)

(h)

(cid:145)guard for a removable mechanical transmission device(cid:146)
means a device protecting persons exposed from the risk
of being dragged along by a removable transmission
mechanical device;

(cid:145)portable cartridge-operated device(cid:146) means a portable
device intended for industrial or technical use making
use of an explosive charge in the form of a cartridge,
for the purposes of:

(d)

(cid:145)safety component(cid:146) means a component included in the list
below which is independently placed on the market in
order to be installed on machinery already in use or on
second-hand machinery:

(i) fixing a metal part in a material, or

(ii) slaughtering animals, or

(i) components referred to in points 19 and 20 of

(iii) marking an object by cold engraving, or

Annex IV,

(iv) crimping cables;

(i)

(j)

(k)

(ii) safety logic units for an emergency stop or movable

guard control circuit,

(iii) solenoid valves controlling dangerous movements of

machinery,

(iv) smoke and dust extraction systems for machinery,

(v) guards and protection devices and their

locking

mechanisms for machinery,

(vi) control devices for calling lifting appliances and

anti-fall devices for hoists,

(vii) devices

for preventing

lifting

appliances

from

colliding,

(viii) safety belts and seat harnesses,

(ix) non-return valves

for

installation on hydraulic

circuits,

(x) guards
devices;

for

removable mechanical

transmission

(e)

(cid:145)lifting accessory(cid:146) means a component or equipment not
attached to the lifting machinery, allowing the load to be
held, and placed between the machinery and the load or
on the load itself, or constituting an integral part of the
load; slings and their components are also regarded as
lifting accessories;

(f)

(cid:145)removable mechanical
a
removable component for transmitting power between a

transmission device(cid:146) means

(cid:145)partly completed machinery(cid:146) means an assembly, fitted or
intended to be fitted with a drive system, of linked parts
or mechanical components which are almost a machine
but which
specific
themselves
application. Partly completed machinery is intended to
be incorporated into or assembled with one or more
machines or other partly completed machinery, thereby
forming a single machine to which this Directive applies;

perform a

cannot

(cid:145)placing on the market(cid:146) means making available for the
first time in the Community machinery intended for an
end user, whether for reward or free of charge;

(cid:145)manufacturer(cid:146) means any natural or legal person who
designs or manufactures machinery covered by this
Directive, with a view to placing it on the market, under
his own name or trademark. The manufacturer may also
be:

(i) any natural or legal person who designs or manu-
factures a machine covered by this Directive, or who
has such a machine designed or manufactured, for his
own use,

(ii) any natural or legal person who, when a machine
covered by this Directive is placed on the market or
put into service, is responsible for its conformity to
this Directive;

(l)

(cid:145)authorised representative(cid:146) means any natural or
legal
person established in the Community who has received a
written mandate from the manufacturer to perform on his
behalf all or part of
the obligations and formalities
connected with this Directive;

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(m) (cid:145)putting into service(cid:146) means the first use, for its intended
purpose, in the Community, of a machine covered by this
Directive. Machinery which, prior to its first use, does not
require any installation or adjustment by the manufacturer
or by a third party designated by him is considered to
have been put
is placed on the
market;

into service when it

(n)

for Standardisation (CEN),

(cid:145)harmonised standard(cid:146) means a non-binding technical spec-
ification adopted by a standardisation body, namely the
European Committee
the
European Committee for Electrotechnical Standardisation
(Cenelec) or the European Telecommunications Standards
Institute (ETSI), adopted on the basis of a remit issued by
the Commission in accordance with the procedures laid
down in Directive 98/34/EC of the European Parliament
and of the Council (1).

Article 3

Specific Directives

4. Member States shall define the tasks, organisation and
powers of the competent authorities referred to in paragraph
3 and shall notify the Commission and other Member States
thereof and also of any subsequent amendment.

Article 5

Placing on the market

Before placing a machine on the market and/or putting it
1.
into service, the manufacturer or his authorised representative
must ensure that:

(a) it satisfies the essential health and safety requirements set

out in Annex I;

(b) the conformity assessment procedures referred to in Article

12 have been completed.

Before placing partly completed machinery on the
the manufacturer or his authorised representative
the procedures referred to in Article 13

2.
market,
must ensure that
have been completed.

To the extent that, for a machine, the risks referred to in
1.
this Directive
specifically by other
Community Directives, this Directive shall not apply, or shall
cause to apply, in the case of such machinery and of such risks
on the implementation of those Directives.

covered more

are

3.
For the purposes of the procedure referred to in Article
12, the manufacturer or his authorised representative must
have, or have access to, the necessary means of ensuring that
the machine
safety
requirements set out in Annex I.

essential health and

satisfies

the

regards

2.
In the case of machinery intended to be used by a
intended to protect
the provisions
consumer, as
health and safety which are not covered either by this
Directive or by other specific Community texts, the provisions
of Council Directive 92/59/EEC (2) shall apply.

4. Where machinery is also the subject of other Community
Directives relating to other aspects and providing for the
affixing of the CE marking, the latter shall indicate that the
machinery also conforms to the provisions of
those other
Directives.

Article 4

Market surveillance

1. Member States shall
take all appropriate measures to
ensure that machinery may be placed on the market and/or
put into service only if it does not endanger the health and
safety of persons and, where appropriate, domestic animals or
property, when properly installed and maintained and used for
its intended purpose or under conditions which can reasonably
be foreseen.

2. Member States shall
take all appropriate measures to
ensure that partly completed machinery can be placed on the
market only if
the
Directive.

the relevant provisions of

it satisfies

3. Member States shall institute or appoint the competent
authorities to monitor the conformity of machinery with the
provisions set out in paragraphs 1 and 2.

(1) OJ L 204, 21.7.1998, p. 37, as amended by Directive 98/48/EC (OJ

L 217, 5.8.1998, p. 18).
(2) OJ L 228, 11.8.1992, p. 24.

However, where one or more of those Directives allow the
manufacturer or his authorised representative to choose,
during a transitional period, the system to be applied, the CE
indicate conformity only to the provisions of
marking shall
those Directives applied by the manufacturer or his authorised
representative.

Particulars of the Directives applied, as published in the Official
Journal of the European Communities, must be given on the EC
declaration of conformity which accompanies the machine.

Article 6

Freedom of movement

1. Member States may not prohibit, restrict or impede the
placing on the market and/or putting into service in their
territory of machinery which complies with this Directive in
respect of the risks which it covers.

2. Member States may not prohibit, restrict or impede the
placing on the market of partly completed machinery where
the manufacturer or his authorised representative makes a
declaration of incorporation, referred to in Annex II, part B,
stating that
to be incorporated into machinery or
assembled with other partly completed machinery to form a
machine.

is

it

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At trade fairs, exhibitions, demonstrations, etc., Member
3.
States shall not prevent the showing of machines which do not
conform to this Directive, provided that a visible sign clearly
they are not
they do not conform and that
indicates that
into conformity by
they have been brought
available until
the manufacturer or his authorised representative. Furthermore,
during demonstrations of such non-conforming machinery,
adequate safety measures
the
protection of persons.

shall be taken to ensure

Article 7

Presumption of conformity

1. Member States shall consider that machinery bearing the
CE marking and accompanied by the EC declaration of
conformity, the contents of which are set out in Annex II,
part A, comply with the provisions of this Directive.

in
the references

conformity with
a
2. Machinery manufactured
to which have been
harmonised standard,
published in the Official Journal of
the European Communities,
shall be presumed to comply with the essential health and
safety requirements covered by such harmonised standard.

The Commission shall publish in the Official Journal of the
the harmonised

references of

the

3.
European Communities
standards.

4. Member States shall take the appropriate measures to
enable the social partners to have an influence at national
level on the process of preparing and monitoring the
harmonised standards.

Article 8

Specific measures

1.
The Commission may, acting in accordance with the
procedure referred to in Article 22(3), take any appropriate
to the
measure
following points:

the provisions

to implement

relating

(a) updating of the list of safety components referred to in

point (d) of the second paragraph of Article 2;

(b) arrangements

for cooperation between Member States

provided for in Article 19;

(c) updating of the list of machinery referred to in Annex I,
for which a rollover protective structure is

point 3.4.2.
obligatory;

(d) updating of the list of machinery referred to in Annex I,
point 1.6.11.2 for which information on non-ionising
radiation must be supplied;

(e) prohibition of

the placing on the market of machinery

referred to in Article 9.

measure connected with the implementation and practical
application of this Directive.

Article 9

Specific measures to deal with categories of potentially
hazardous machinery

Where a Member State considers, with regard to a given
to
it
category of machinery that
protect safety and health, to prohibit or restrict its placing
on the market or make it subject
it
shall take or envisage all necessary and justified transitional
measures. It shall then inform the Commission and the other
Member States thereof, indicating its reasons.

to special conditions,

is necessary,

in order

The Commission shall consult the Member States and other
interested parties, indicating to them the measures it intends
to take at Community level. The Commission shall adopt, if the
national measures are justified and if Community action can
ensure a high level of protection of the health and safety of its
citizens,
the
procedure referred to in Article 22(3).

the Community measures necessary under

Article 10

Procedure for disputing a harmonised standard

Where a Member State or the Commission considers that a
harmonised standard referred to in Article 7(2) does not
entirely satisfy the essential health and safety requirements
the
which it covers and which are set out
Commission or
the Member State shall bring the matter
before the committee instituted by Directive 98/34/EC setting
out
the reasons therefor. The committee shall deliver an
opinion without delay.

in Annex I,

In the light of the committee’s opinion, the Commission shall
decide not to publish, to publish with restriction, to maintain
or to withdraw the references to the harmonised standard
concerned in the Official Journal of the European Communities.

Article 11

(cid:145)Product(cid:146) safeguard clause

1. Where a Member State ascertains that machinery, bearing
the CE marking, accompanied by the EC declaration of
conformity and used in accordance with its intended purpose
or under conditions which can reasonably be foreseen, is liable
to compromise the health and safety of persons and, where
appropriate, domestic animals or property it shall
take all
appropriate measures to withdraw such machinery from the
market, to prohibit the placing on the market and/or putting
into service or to restrict free movement thereof.

The Member State shall immediately inform the Commission of
any such measure indicating the reasons for its decision and, in
particular whether the non-conformity is due to:

2.
The Commission may, acting in accordance with the
procedure referred to in Article 22(2), take any appropriate

(a)

failure to satisfy the essential requirements referred to in
Article 5(1);

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(b) incorrect application of the harmonised standards referred

(b) the EC type-examination procedure provided for

in

to in Article 7(2);

Annex X;

(c) shortcomings

in the harmonised standards

themselves

referred to in Article 7(2).

(c) the full quality assurance procedure provided for

in

Annex XI.

2.
The Commission shall enter into consultation with the
parties concerned without delay. Where the Commission
considers, after this consultation, that the measure is justified,
it shall immediately so inform the Member State which took
the initiative and the other Member States. Where the
Commission considers,
the
measure is not justified,
immediately so inform the
Member State which took the initiative and the manufacturer
or his authorised representative. Where the decision referred to
in paragraph 1 is based on a shortcoming in the harmonised
standards,
to the
the Commission shall
committee instituted by Directive 98/34/EC if
the Member
State at the origin of the decision maintains its position, and
the Commission or
initiate the
procedure referred to in Article 10.

the Member State shall

after
it shall

consultation,

the matter

refer

that

this

3. Where machinery does not conform and bears the CE
marking, the competent Member State shall take appropriate
action against whomsoever has affixed the marking and shall
so inform the Commission and the other Member States.

The Commission shall ensure that Member States are kept

4.
informed of the progress and outcome of the procedure.

Article 12

Procedures for the conformity assessment of machinery

1.
Following the risk analysis described in Annex I, point
1.1.2, the manufacturer or his authorised representative shall
apply one of the procedures for the assessment of conformity
described in paragraphs 2 to 5.

2. Where the risk analysis enables the conclusion to be
drawn that the Directive has no relevance, the manufacturer
or his authorised representative shall apply the simplified
procedure described in Annex VIII.

3. Where the risk analysis does not enable the conclusion to
the Directive has no relevance and the
be drawn that
machinery is not referred to in Annex IV, the manufacturer
or his authorised representative shall,
in order to certify its
conformity with the provisions of this Directive, apply the
procedure for assessment of conformity with internal checks
on the manufacture provided for in Annex VII.

4. Where the risk analysis does not enable the conclusion to
be drawn that
the Directive has no relevance and the
machinery is referred to in Annex IV and manufactured in
accordance with the harmonised standards
referred to in
Article 7(2) and provided that those standards cover all of
the relevant risks, the manufacturer or his authorised represen-
to certify its conformity with the
tative shall,
the following
provisions of
procedures:

this Directive, apply one of

in order

(a) the procedure for adaptation to harmonised standards

provided for in Annex IX;

5. Where the risk analysis does not enable the conclusion to
be drawn that
the Directive has no relevance and the
machinery is referred to in Annex IV and has not been manu-
factured in accordance with the harmonised standards referred
to in Article 7(2), or only partly in accordance with such
standards, or
the
machinery in question,
the manufacturer or his authorised
in order to certify its conformity with
representative shall,
the provisions of this Directive, apply one of the following
procedures:

if no harmonised standards exist

for

(a) the EC type-examination procedure provided for in Annex

X;

(b) the full quality assurance procedure provided for in Annex

XI.

Article 13

Procedure for partly completed machinery

The manufacturer of partly completed machinery or his auth-
orised representative must, before placing it on the market:

(a) draw up a declaration of incorporation described in Annex
II, part B, which must accompany the partly completed
machinery until
complete
machine and shall then form part of the technical file for
that machine,

incorporated into a

is

it

(b) prepare a notice of assembly described in Annex V.

Article 14

Notified bodies

1. Member States shall notify the Commission and the other
Member States of the bodies which they have appointed to
carry out the assessment of conformity for placing on the
market referred to in Article 12(4) and (5), together with the
specific tasks which these bodies have been appointed to carry
out
assigned to them
beforehand by the Commission.

identification numbers

and the

2.
The Commission shall publish in the Official Journal of the
European Communities, for information, a list of the notified
bodies and their identification numbers and the tasks for
which they have been notified. The Commission shall ensure
that this list is kept up to date.

3. Member States shall apply the criteria referred to in
in assessing the bodies to be notified. Bodies
Annex XII
meeting the assessment criteria laid down in the relevant
the references of which shall be
harmonised standards,
published in the Official
the European Communities
Journal of
pursuant to this Directive, shall be presumed to fulfil those
criteria.

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A Member State which has designated a body must

4.
withdraw its notification if it finds:

(c) the affixing, on machinery, of a marking other than the CE

marking which is prohibited under Article 16.

(a) that the body no longer meets the criteria referred to in

Annex XII, or

(b) that certificates have repeatedly been issued to models of
machinery which do not satisfy the essential health and
safety requirements set out in Annex I.

It shall
Member States accordingly.

immediately inform the Commission and the other

Article 15

Installation and use of machinery

This Directive shall not affect Member States’ entitlement
1.
to lay down,
in due observance of Community law, such
requirements as they may deem necessary to ensure that
persons, and in particular workers, are protected when using
such
machinery, provided that
machinery is modified in a way not specified in this Directive.

this does not mean that

2. Member States shall take whatever measures they deem
necessary to ensure that their laws, regulations and adminis-
trative provisions relating to the installation and/or use of
machinery are brought
the parties
concerned. They shall inform the Commission thereof.

to the attention of

Article 16

CE marking

The CE conformity marking shall consist of the initials

1.
(cid:145)CE(cid:146) as shown in Annex III.

2.
The CE marking shall be affixed to the machinery
distinctly and visibly in accordance with point 1.9 of Annex I.

3.
The affixing on machinery of markings which are likely
to mislead third parties as to the meaning or form of the CE
marking shall be prohibited.

Any other marking may be affixed to the machinery provided
that the visibility, legibility and meaning of the CE marking is
not thereby impaired.

Where a Member State ascertains that marking does not
conform,
the manufacturer or his authorised representative
shall be obliged to make the machinery conform to the
relevant provisions of this Directive and put an end to the
infringement under conditions fixed by that Member State.

Where non-conformity persists, the Member State shall take all
appropriate measures to restrict or prohibit the placing on the
market of the machinery in question or to ensure that it is
withdrawn from the market in accordance with the procedure
laid down in Article 11.

Article 18

Confidentiality

Without prejudice to existing national provisions and practices
in the area of confidentiality, Member States shall ensure that
all parties concerned by the application of this Directive are
bound to treat as confidential the information obtained in the
execution of
their tasks which is covered by professional
secrecy, unless the divulging of such information is necessary
in order to protect the health and safety of persons.

The provisions of the first subparagraph shall not affect the
obligations of the Member States and the notified bodies with
regard to mutual information and the issuing of warnings, nor
the obligations to provide information incumbent on the
persons concerned under criminal law.

The decisions
Commission under Articles 9 and 11 must be published.

taken by the Member States and by the

Article 19

Cooperation between Member States

Member States shall take the appropriate measures to ensure
the competent authorities referred to in Article 4(3)
that
cooperate with each other and transmit
to each other the
information necessary to enable this Directive to be applied
uniformly.

Article 17

Non-conformity of marking

Article 20

Right of defence

Member States shall consider the following marking not to
conform:

(a) the affixing of the CE marking pursuant to this Directive on

machinery not covered by this Directive;

(b) the absence of the CE marking and/or EC declaration of

conformity for machinery;

Any measure taken pursuant to this Directive which restricts
the placing on the market and/or putting into service of a
machine covered by this Directive shall
state the exact
is based. Such a measure shall be
grounds on which it
notified as soon as possible to the party concerned, who
shall at
the legal remedies
available to him under the laws in force in the Member State
concerned and of the time limits to which such remedies are
subject.

the same time be informed of

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Article 21

Dissemination of information

Appliances moving along a fixed course even where they do
not move along guides which are rigid shall fall within the
scope of this Directive.

The Commission will take the necessary measures for appro-
this
priate information concerning the implementation of
Directive to be made available.

3.

This Directive shall not apply to:

Article 22

Committee

The Commission shall be assisted by a committee, here-
composed of
(cid:145)Machinery Committee(cid:146),
the Member States and chaired by the

1.
inafter
representatives of
representative of the Commission.

called the

2. Where reference is made to this paragraph, the advisory
procedure laid down in Article 3 of Decision 1999/468/EC
shall apply, in compliance with Article 7 and Article 8 thereof.

3. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply, in compliance with Article 7 and Article 8 thereof.

(cid:151) hoists for persons or for persons and goods, whose

speed is not greater than 0,15 m/s,

(cid:151) cableways, including funicular railways,

(cid:151) lifts specially designed and constructed for military or

police purposes,

(cid:151) platforms intended for

raising/lowering persons and

from which work can be carried out,

(cid:151) mine winding gear,

(cid:151) theatre elevators for persons,

(cid:151) lifts fitted in means of transport,

The period provided for
1999/468/EC shall be three months.

in Article 5(6) of Decision

(cid:151) lifts connected to machinery and intended exclusively

for access to the workstation,

Article 23

Penalties

(cid:151) appliances for persons with limited mobility, the load
support of which moves along the inclined plain of a
staircase,

Member States shall lay down the rules on penalties applicable
to infringements of the national provisions adopted pursuant to
this Directive and shall take all measures necessary to ensure
that they are implemented. The penalties provided for must be
effective, proportionate and dissuasive. Member States shall
to the Commission by the date
notify those provisions
specified in the first subparagraph of Article 26(1) at
the
latest and shall notify it without delay of any subsequent
amendment affecting them.

Article 24

Amendment of Directive 95/16/EC

Directive 95/16/EC is amended as follows:

1. In Article 1, paragraphs 2 and 3 are replaced by the

following:

For the purposes of this Directive, (cid:147)lift(cid:148) shall mean an
(cid:145)2.
appliance serving specific levels, having a load support
moving along guides which are rigid and inclined at an
angle of more than 15 degrees to the horizontal, intended
for the transport of:

(cid:151) escalators and mechanical walkways.(cid:146)

2. In Annex I, point 1.2 is replaced by the following:

(cid:145)1.2. Load support

The load support of each lift must be a car. This car
must be designed and constructed to offer the space
and strength corresponding to the maximum number
of persons and the rated load of the lift set by the
installer.

Where the lift is intended for the transport of persons,
and where its dimensions permit, the car must be
its
designed and constructed in such a way that
structural features do not obstruct or impede access
and use by disabled persons and so as to allow any
appropriate adjustments intended to facilitate their
access.(cid:146)

Article 25

Repeal

Directive 98/37/EC is repealed.

(cid:151) persons,

(cid:151) persons and goods.

References in Community acts to the repealed Directive shall
be construed as references to this Directive and shall be read in
accordance with the correlation table in Annex XIII.

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Article 26

Implementation

2. Member States shall communicate to the Commission the
text of the provisions of national law which they adopt in the
field covered by this Directive.

1. Member States shall adopt and publish before 30 June
regulations and administrative provisions
2004 the laws,
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

They shall apply those provisions with effect from 1 January
2006.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
their official publication.
reference on the occasion of
Member States shall determine how such reference is to be
made.

Article 27

Entry into force

This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

Article 28

Addressees

This Directive is addressed to the Member States.

ANNEX I

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION
OF MACHINES

PRELIMINARY OBSERVATIONS

1. The manufacturer of a machine or his authorised representative is under an obligation to assess the hazards in order
to identify all of those which apply to his machine; he must then design and construct it taking account of his
assessment.

2. The obligations laid down by the essential health and safety requirements apply only when the corresponding hazard
exists for the machinery in question when it is used under the conditions foreseen by the manufacturer or his
authorised representative but also in foreseeable abnormal situations. In any event, the principle of safety integration
(requirement 1.1.2) and the obligations of marking and supplying instructions (requirements 1.9 and 1.10.2) apply to
all machinery with the exception of machinery referred to in Article 12, paragraph 2 which present no risks.

3. The essential health and safety requirements laid down in this Annex are mandatory. However, taking into account
the state of the art and prohibitive economic imperatives, it may not be possible to meet the objectives set by them.
In this case, the machinery must as far as possible be designed and constructed with the purpose of approaching
those objectives.

4. The essential health and safety requirements have been grouped according to the categories of machinery. Never-
theless, it is essential to take account of the whole of this Annex in order to be able to meet all the relevant essential
requirements. Machinery presents a series of hazards which may be covered under more than one heading of this
Annex.

1.

1.1.

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

General remarks

1.1.1.

Definitions

For the purpose of this Annex:

1.

(cid:145)danger zone(cid:146) means any zone within and/or around machinery in which an exposed person is subject to a
risk to his health or safety;

2.

(cid:145)exposed person(cid:146) means any person wholly or partially in a danger zone;

3.

(cid:145)operator(cid:146) means the person or persons given the task of installing, operating, adjusting, maintaining,
cleaning, repairing or moving machinery;

4.

(cid:145)hazardous situation(cid:146) means any situation in which a person is exposed to one or more risks;

5.

(cid:145)risk(cid:146) means a combination of the probability and the degree of an injury or damage to health that can
arise in a hazardous situation;

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6.

(cid:145)guard(cid:146) means a part of a machine used specifically to provide protection by means of a physical barrier;

7.

(cid:145)protective device(cid:146) means a device (other than a guard) which eliminates a potential danger or reduces the
risk to an acceptable level, alone or in conjunction with a guard.

1.1.2.

Principles of safety integration

(a) Machinery must be so constructed that it is fitted for its function, and can be adjusted and maintained
without putting persons at risk when these operations are carried out under the conditions foreseen by the
manufacturer but also in foreseeable abnormal situations.

The aim of measures taken must be to eliminate any risk of accident throughout the foreseeable lifetime of
the machinery, including the phases of assembly, dismantling, disabling and scrapping.

(b) In selecting the most appropriate methods, the manufacturer must apply the following principles, in the

order given:

(cid:151) eliminate or reduce risks as far as possible (inherently safe machinery design and construction),

(cid:151) take the necessary protective measures in relation to risks that cannot be eliminated,

(cid:151) inform users of the residual risks due to any shortcomings of the protective measures adopted,
indicate whether any particular training is required and specify any need to provide personal
protective equipment.

(c) When designing and constructing machinery, and when drafting the instructions, the manufacturer or his
authorised representative must envisage not only the normal use of the machinery but also uses of it
which could reasonably be expected.

The machinery must be so designed and constructed as to prevent abnormal use if such use would
engender a risk. Where appropriate, the instructions must draw the user’s attention to ways (cid:151) which
experience has shown might occur (cid:151) in which the machinery should not be used.

(d) Machinery must be so designed and constructed as to take account of the constraints to which the
operator is subject as a result of the necessary or foreseeable use of personal protective equipment.

(e) Machinery must be supplied with all the essential special equipment and accessories to enable it to be

adjusted, maintained and used without risk.

1.1.3.

Ergonomics

Under the intended conditions of use, the discomfort, fatigue and psychological stress faced by the operator
must be reduced to the minimum possible taking ergonomic principles into account.

1.1.4.

Materials and products

The materials used to construct machinery or products used and created during its use must not endanger
exposed persons’ safety or health.

In particular, where fluids are used, machinery must be designed and constructed for use without risks due to
filling, use, recovery or draining.

1.1.5.

Lighting

Machinery must be supplied with integral lighting suitable for the operations concerned where its lack is likely
to cause a hazard despite ambient lighting of normal intensity.

Machinery must be so designed and constructed that there is no area of shadow likely to cause nuisance, that
there is no irritating dazzle and that there are no dangerous stroboscopic effects due to the lighting provided
by the manufacturer.

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The essential requirement described in section 3.1.2 also applies to fixed machinery intended for use outside
and for which night work is foreseen.

Internal parts requiring frequent inspection, and adjustment and maintenance areas, must be provided with
appropriate lighting.

1.1.6.

Design of machinery to facilitate its handling

Machinery or each component part thereof must:

(cid:151) be capable of being handled safely,

(cid:151) be packaged or designed so that it can be stored safely and without damage.

During the transportation of the machine and/or its parts, there must be no possibility of sudden movements
or of hazards due to instability as long as the machine and/or its parts are handled in accordance with the
instructions of the manufacturer or of his authorised representative.

Where the weight, size or shape of machinery or its various component parts prevents them from being
moved by hand, the machinery or each component part must:

(cid:151) either be fitted with attachments for lifting gear, or

(cid:151) be designed so that it can be fitted with such attachments.

(cid:151) be shaped in such a way that standard lifting gear can easily be attached.

Where machinery or one of its component parts is to be moved by hand, it must:

(cid:151) either be easily movable, or

(cid:151) be equipped for picking up and moving in complete safety.

Special arrangements must be made for the handling of tools and/or machinery parts, even if lightweight,
which could be hazardous.

1.2.

Controls

1.2.1.

Safety and reliability of control systems

Control systems must be designed and constructed so that they are safe and reliable, in a way that will prevent
a hazardous situation arising. Above all they must be designed and constructed in such a way that:

(cid:151) they can withstand the rigours of normal use and external factors,

(cid:151) human error during operation does not lead to hazardous situations.

1.2.2.

Manual controls

Manual controls must be:

(cid:151) clearly visible and identifiable; the use of pictograms is recommended,

(cid:151) positioned for safe operation without hesitation or loss of time, and without ambiguity,

(cid:151) designed so that the movement of the manual control is consistent with its effect,

(cid:151) located outside the danger zones, except where necessary for certain controls, such as the emergency stop

and the console for training of robots,

(cid:151) positioned so that their operation cannot cause additional risk,

(cid:151) designed or protected so that the desired effect, where a risk is involved, cannot occur without an

intentional operation,

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(cid:151) made so as to withstand foreseeable strain; particular attention must be paid to emergency stop devices

liable to be subjected to considerable strain.

Where a manual control is designed and constructed to perform several different actions, namely where there
is no one-to-one correspondence, the action to be performed must be clearly displayed and subject to
confirmation where necessary.

Manual controls must be so arranged that their layout, travel and resistance to operation are compatible with
the action to be performed, taking account of ergonomic principles.

Machinery must be fitted with indicators as required for safe operation. The operator must be able to read
them from the control position.

From each control position the operator must be able to ensure that there are no persons in the danger zones.

If this is impossible, the control system must be designed and constructed so that, whenever the machinery is
about to start, an acoustic and/or visual warning signal is given which leaves enough time for the exposed
person to leave the danger zone or prevent the machinery starting up.

If necessary, means must be provided to ensure that the machinery can be controlled only from control
positions located in one or more predetermined zones or locations.

1.2.3.

Starting

It must be possible to start machinery only by voluntary actuation of a manual control provided for the
purpose.

The same requirement applies:

(cid:151) when restarting the machinery after a stoppage, whatever the cause,

(cid:151) when effecting a significant change in the operating conditions.

However, the restarting of the machinery or a change in operating conditions may be effected by voluntary
actuation of a device other than the manual control provided for the purpose, unless this would lead to a
hazardous situation.

As an exception to the above requirements, for automated plant functioning in automatic mode, the starting
of the machinery, or restarting after a stoppage, or a change in operating conditions must be possible without
intervention, provided this does not lead to a hazardous situation for the operator and/or exposed persons.

1.2.4.

Stopping device

1.2.4.1. N o r m a l s t o p p i n g

Each machine must be fitted with a manual control whereby the machine can be brought safely to a complete
stop.

Each workstation must be fitted with a manual control to stop some or all of the moving parts of the
machinery, depending on the type of risk, so that the machinery is rendered safe.

The machinery’s stop control must have priority over the start controls.

Once the machinery or its dangerous parts have stopped, the energy supply to the actuators concerned must
be cut off.

1.2.4.2.

E m e r g e n c y s t o p

Each machine must be fitted with one or more emergency stop devices to enable actual or impending danger
to be averted.

The following exceptions apply:

(cid:151) machines in which an emergency stop device would not lessen the risk, either because it would not reduce
the stopping time or because it would not enable the special measures required to deal with the risk to be
taken,

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(cid:151) hand-held portable machines and hand-guided machines.

This device must:

(cid:151) have clearly identifiable, clearly visible and quickly accessible manual controls,

(cid:151) stop the hazardous process as quickly as possible, without creating additional risks,

(cid:151) where necessary, trigger or permit the triggering of certain safeguard movements.

Once active operation of the emergency stop control has ceased following a stop command, that command
must be sustained by engagement of the emergency stop device until that engagement is specifically over-
ridden; it must not be possible to engage the device without triggering a stop command; it must be possible to
disengage the device only by an appropriate operation, and disengaging the device must not restart the
machinery but only permit restarting.

1.2.4.3. C o m p l e x i n s t a l l a t i o n s

In the case of machinery or parts of machinery designed to work together, the machinery must be so designed
and constructed that the stop controls, including emergency stop devices, can stop not only the machinery
itself but also all equipment upstream and/or downstream if its continued operation can be dangerous.

1.2.5.

Control or operating mode selector

The control mode selected must override all other control or operating modes with the exception of the
emergency stop.

If machinery has been designed and built to allow its use in several control or operating modes presenting
different safety levels, it must be fitted with a mode selector which can be locked in each position. Each
position of the selector must correspond to a single operating or control mode.

The selector may be replaced by another selection method which restricts the use of certain functions of the
machinery to certain categories of operator.

If, for certain operations, the machinery must be able to operate with its protection devices neutralised, the
control or operating mode selector must simultaneously:

(cid:151) disable the automatic control mode,

(cid:151) permit movements only by manual controls requiring sustained action,

(cid:151) permit the operation of dangerous moving parts only in enhanced safety conditions while preventing

hazards from linked sequences,

(cid:151) prevent any movement liable to pose a danger by acting voluntarily or involuntarily on the machine’s

internal sensors and any uncontrolled movement.

In addition, the operator must be able to control operation of the parts he is working on from the adjustment
point.

1.2.6.

Failure of the power supply

The interruption, re-establishment after an interruption or fluctuation in whatever manner of the power
supply to the machinery must not lead to dangerous situations.

1.2.7.

Control circuit failure

A fault in the control circuit logic, or failure of or damage to the control circuit must not lead to dangerous
situations.

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1.2.8.

Software

Any interactive software between the operator and the command or control system of a machine must be
user-friendly.

1.3.

Protection against mechanical hazards

1.3.1.

Stability

Machinery and its components and fittings must be so designed and constructed that they are stable enough
for use without risk of overturning, falling or unexpected movement.

This requirement also applies during transportation, assembly, dismantling, scrapping and any other action
involving the machinery.

If the shape of the machinery itself or its intended installation does not offer sufficient stability, appropriate
means of anchorage must be incorporated and indicated in the instructions.

1.3.2.

Risk of break-up during operation

The various parts of machinery and their linkages must be able to withstand the stresses to which they are
subject when used.

The durability of the materials used must be adequate for the nature of the workplace.

The manufacturer or his authorised representative must indicate in the instructions the type and frequency of
inspections and maintenance required for safety reasons. He must, where appropriate,
indicate the parts
subject to wear and the criteria for replacement.

Where a risk of rupture or disintegration remains despite the measures taken, the moving parts must be
mounted and positioned in such a way that in case of rupture their fragments will be contained and prevented
from reaching workstations.

Both rigid and flexible pipes carrying fluids, particularly those under high pressure, must be able to withstand
the foreseen internal and external stresses and must be firmly attached and/or protected against all manner of
external stresses and strains; precautions must be taken to ensure that no risk is posed by a rupture.

Where the material to be processed is fed to the tool automatically, the following conditions must be fulfilled
to avoid risks to the exposed persons:

(cid:151) when the workpiece comes into contact with the tool, the latter must have attained its normal working

conditions,

(cid:151) when the tool starts and/or stops (intentionally or accidentally)

the feed movement and the tool

movement must be coordinated.

1.3.3.

Risks due to falling or ejected objects

Precautions must be taken to prevent risks from falling or ejected objects.

1.3.4.

Risks due to surfaces, edges or angles

In so far as their purpose allows, accessible parts of the machinery must have no sharp edges, no sharp angles,
and no rough surfaces likely to cause injury.

1.3.5.

Risks related to combined machinery

Where the machinery is intended to carry out several different operations with the manual removal of the
piece between each operation (combined machinery), it must be designed and constructed in such a way as to
enable each element to be used separately without the other elements constituting a danger or risk for the
exposed person.

For this purpose, it must be possible to start and stop separately any elements that are not protected.

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1.3.6.

Risks relating to variations in the rotational speed of tools

When the machinery performs operations under different conditions of use,
it must be designed and
constructed in such a way that selection and adjustment of these conditions can be carried out safely and
reliably.

1.3.7.

Prevention of risks related to moving parts

The moving parts of machinery must be designed, built and laid out in such a way as to prevent risk of
contact which could lead to accidents or, where risks persist, fitted with guards or protective devices.

All necessary steps must be taken to prevent accidental blockage of moving parts involved in the work. In
cases where, despite the precautions taken, a blockage is likely to occur, specific protection devices or tools
must be provided to enable the equipment to be safely unblocked.

The instructions and possibly a sign on the machinery should indicate these specific protection devices.

1.3.8.

Choice of protection against risks caused by moving parts

Guards or protection devices used to protect against the risks caused by moving parts must be selected on the
basis of the type of risk. The following guidelines must be used to help make the choice.

1.3.8.1. M o v i n g t r a n s m i s s i o n p a r t s

Guards designed to protect exposed persons against the risks associated with moving transmission parts must
be:

(cid:151) either fixed guards as referred to in section 1.4.2.1,

(cid:151) or movable guards of type A as referred to in section 1.4.2.2,

Movable guards should be used where frequent access is foreseen.

1.3.8.2. M o v i n g p a r t s d i r e c t l y i n v o l v e d i n t h e w o r k p r o c e s s

Guards or protection devices designed to protect exposed persons against the risks associated with moving
parts directly involved in the process must be:

(cid:151) either fixed guards as referred to in section 1.4.2.1,

(cid:151) or movable guards of type B as referred to in section 1.4.2.2,

(cid:151) or protection devices as referred to in section 1.4.3.

However, when certain moving parts directly involved in the process cannot be made completely or partially
inaccessible during operation owing to operations requiring nearby operator intervention, where technically
possible such parts must be fitted with:

(cid:151) fixed guards, preventing access to those sections of the parts that are not used in the work,

(cid:151) adjustable guards as referred to in section 1.4.2.3.

1.3.9.

Uncontrolled movements

When a part of a machine has been stopped, any drift away from the stopping position, for whatever reason
other than action at the controls, must be such that it is not a hazard to exposed persons.

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1.4.

Required characteristics of guards and protection devices

1.4.1.

General requirements

Guards and protection devices must:

(cid:151) be of robust construction,

(cid:151) be securely held in place,

(cid:151) not give rise to any additional risk,

(cid:151) not be easy to by-pass or render non-operational,

(cid:151) be unable to remain in place without their fixings,

(cid:151) be located at an adequate distance from the danger zone,

(cid:151) cause minimum obstruction to the view of the production process,

(cid:151) enable essential work to be carried out on installation and/or replacement of tools and also for main-
tenance by restricting access only to the area where the work has to be done, if possible without the guard
or protection device having to be dismantled.

1.4.2.

Special requirements for guards

1.4.2.1.

F i x e d g u a r d s

They must be fixed by systems that can be opened only with tools. Their fixing systems must remain attached
to the guards when removed.

1.4.2.2. M o v a b l e g u a r d s

A. Type A movable guards must:

(cid:151) as far as possible remain attached to the machinery when open,

(cid:151) be associated with a locking device:

(cid:151) to prevent moving parts starting up as long as these parts can be accessed,

(cid:151) and to give a stop command whenever they are no longer closed.

B. Type B movable guards must:

(cid:151) as far as possible remain fixed to the machinery when open,

(cid:151) be so designed and constructed that:

(cid:151) they can be adjusted only by means of an intentional action,

(cid:151) the absence or failure of one of their components prevents starting or stops the moving parts,

(cid:151) protection against any risk of ejection is provided by means of an appropriate barrier,

(cid:151) be associated with an interlocking device preventing:

(cid:151) moving parts from starting up while they are within the operator’s reach,

(cid:151) the exposed person from reaching moving parts once they have started up.

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1.4.2.3. A d j u s t a b l e g u a r d s r e s t r i c t i n g a c c e s s

Adjustable guards restricting access to those areas of the moving parts strictly necessary for the work must:

(cid:151) be adjustable manually or automatically according to the type of work involved,

(cid:151) be readily adjustable without the use of tools,

(cid:151) reduce as far as possible the risk of ejection.

1.4.3.

Special requirements for protection devices

Protection devices must be designed and constructed so that they can be associated with an interlocking
device preventing:

(cid:151) moving parts from starting up while they are within the operator’s reach,

(cid:151) the exposed person from reaching moving parts once they have started up.

They can be adjusted only by means of an intentional action.

The absence or failure of one of their components prevents starting or stops the moving parts.

1.5.

Required characteristics of operating and/or driving positions

1.5.1.

Operating and/or driving positions

There may be two or more operating and/or driving positions and, in such cases, each position must be
provided with all the requisite manual controls without the operators hindering or endangering each other.

Where there is more than one control position, the machinery must be designed so that the use of one of
them precludes the use of the others, except for stop controls and emergency stops.

The operating and/or driving position must be designed and constructed so as to avoid any health risk due to
exhaust gases and/or lack of oxygen.

The operating and/or driving position must be fitted with an adequate cab if the machine gives rise to a
dangerous environment presenting risks to the health and safety of the operator. The cab must be designed,
constructed and/or equipped to ensure that the driver has good operating conditions and is protected against
any foreseeable hazards. The exit must allow rapid evacuation. Moreover, an emergency exit must be provided
in a direction which is different from the usual exit.

The materials used for the cab and its fittings must be fire-resistant.

1.5.2.

Seating

Where the working conditions so permit, work places constituting an integral part of the machinery must be
equipped with seats.

Where one exists, the driving seat of the operator or driver must enable the driver or operator to maintain a
stable position.

Where the seat is an integral part of the machinery, it must be supplied with it.

If the machinery is subject to vibrations, the seat must be designed in such as way as to reduce the vibrations
transmitted to the operator or driver to the lowest level that is reasonably possible. The seat mountings must
withstand all stresses to which they can be subjected. Where there is no floor beneath the feet of the driver or
operator, footrests covered with a slip-resistant material must be provided.

1.6.

Protection against other hazards

1.6.1.

Electricity supply

Where machinery has an electricity supply it must be designed, constructed and equipped so that all hazards
of an electrical nature are or can be prevented.

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The specific rules in force relating to electrical equipment designed for use within certain voltage limits must
apply to machinery which is subject to those limits. Conformity assessment with regard to electrical hazards is
governed by this Directive.

1.6.2.

Static electricity

Machinery must be so designed and constructed as to prevent or limit the build-up of potentially dangerous
electrostatic charges and/or be fitted with a discharging system.

1.6.3.

Lightning

Machinery which is designed for outdoor use and which may be subject to the direct effects of lightning while
being used must be fitted with a system for conducting the resultant electrical charges to earth.

1.6.4.

Energy supply other than electricity

Where machinery is powered by an energy other than electricity, it must be so designed, constructed and
equipped as to avoid all potential hazards associated with these types of energy.

1.6.5.

Errors of fitting

Errors likely to be made when fitting or refitting certain parts which could be a source of risk must be made
impossible by the design of such parts or, failing this, by information given on the parts themselves and/or the
housings. The same information must be given on moving parts and/or their housings where the direction of
movement must be known to avoid a risk.

Where necessary, the instructions must give further information on these risks.

Where a faulty connection can be the source of risk, incorrect connections must be made impossible by the
design or, failing this, by information given on the pipes, cables, etc. and/or connector blocks.

1.6.6.

Extreme temperatures

Steps must be taken to eliminate any risk of injury caused by contact with or proximity to machinery parts or
materials at high or very low temperatures.

The risk of very hot or very cold material being ejected should be assessed. Where this risk exists, the
necessary steps must be taken to prevent it or, if this is not technically possible, to render it non-dangerous.

1.6.7.

Fire

Machinery must be designed and constructed to avoid all risk of fire or overheating posed by the machinery
itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery.

1.6.8.

Explosion

Machinery must be designed and constructed to avoid any risk of explosion posed by the machinery itself or
by gases, liquids, dust, vapours or other substances produced or used by the machinery.

Machinery must comply, as far as the risk from explosion due to its use in a potentially explosive atmosphere
is concerned, with the provisions of the specific directives in force.

1.6.9.

Noise

Machinery must be so designed and constructed that risks resulting from the emission of airborne noise are
reduced to the lowest level taking account of technical progress and the availability of means of reducing
noise, in particular at source.

1.6.10.

Vibrations

Machinery must be so designed and constructed that risks resulting from vibrations produced by the
machinery are reduced to the lowest level, taking account of technical progress and the availability of
means of reducing vibration, in particular at source.

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1.6.11.

Radiation

1.6.11.1. G e n e r a l

Machinery must be so designed and constructed that any emission of ionising or non-ionising radiation is
limited to the extent necessary for its operation and that the effects on exposed persons are non-existent or
reduced to non-dangerous proportions.

1.6.11.2.

I n s t r u c t i o n s

Where machinery is likely to emit non-ionising radiation which may endanger exposed persons, in particular
persons with active or non-active implantable medical devices,
the instructions must give quantitative
information concerning the radiation emitted for the operator and exposed persons.

Furthermore, this information is mandatory for the following machinery:

(cid:151) welding machines,

(cid:151) induction heaters,

(cid:151) electro-magnets.

1.6.12.

External radiation

Machinery must be so designed and constructed that external radiation does not interfere with its operation.

1.6.13.

Laser equipment

Where laser equipment is used, the following provisions should be taken into account:

(cid:151) laser equipment on machinery must be designed and constructed so as to prevent any accidental radiation,

(cid:151) laser equipment on machinery must be protected so that effective radiation, radiation produced by

reflection or diffusion and secondary radiation do not damage health,

(cid:151) optical equipment for the observation or adjustment of laser equipment on machinery must be such that

no health risk is created by the laser rays.

1.6.14.

Emissions of dangerous substances

Machinery must be so designed, constructed and/or equipped that risks due to dangerous substances which it
produces can be avoided.

Where a risk exists, the machinery must be so equipped that the said substances can be contained and/or
evacuated in order to prevent the risks related to inhalation or the ingestion of dangerous substances.

During normal operation of the machinery, the devices for containment and/or evacuation referred to in the
previous paragraph must be situated as close as possible to the source of emission if the emission is not
produced in an enclosed space which is part of the machinery.

1.6.15.

Risk of being trapped in a machine

Machinery must be designed, constructed or fitted with a means of preventing an exposed person from being
enclosed within it or, if that is impossible, with a means of summoning help.

1.6.16.

Risk of slipping, tripping or falling

Parts of the machinery where persons are liable to move about or stand must be designed and constructed to
prevent persons slipping, tripping or falling on or off these parts.

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1.7.

Maintenance

1.7.1.

Machinery maintenance

Adjustment and maintenance points must be located outside danger zones. It must be possible to carry out
adjustment, maintenance, repair, cleaning and servicing operations while machinery is at a standstill.

If one or more of the above conditions cannot be satisfied for technical reasons, these operations must be
possible without risk (see 1.2.5).

In the case of automated machinery and, where necessary, other machinery, a connecting device for mounting
diagnostic fault-finding equipment must be provided.

Automated machine components which have to be changed frequently must be capable of being removed and
replaced easily and in safety. Access to the components must enable these tasks to be carried out with the
necessary technical means in accordance with a specified operating method.

1.7.2.

Access to operating positions and servicing points

Machinery must be designed and constructed in such a way as to allow access in safety to all areas used for
production, adjustment and maintenance operations.

The movement of exposed persons must be unhindered.

1.7.3.

Isolation of energy sources

Machinery must be fitted with means to isolate it from all energy sources. Such isolators must be clearly
identified. They must be capable of being locked if reconnection could endanger exposed persons. In the case
of machinery supplied with electricity through a plug capable of being plugged into a circuit, separation of the
plug is sufficient provided that the requirement of the following paragraph is met.

The isolator must be capable of being locked also where an operator is unable, from any of the points to
which he has access, to check that the energy is still cut off.

After the energy is cut off, it must be possible to dissipate normally any energy remaining or stored in the
circuits of the machinery without risk to exposed persons.

As an exception to the requirement laid down in the previous paragraph, certain circuits may remain
connected to their energy sources in order, for example, to hold parts, protect information, light interiors,
etc. In this case, special steps must be taken to ensure operator safety.

1.7.4.

Operator intervention

Machinery must be so designed, constructed and equipped that the need for operator intervention is limited.

If operator intervention cannot be avoided, it must be possible to carry it out easily and in safety.

1.7.5.

Cleaning of internal parts

The machinery must be designed and constructed in such a way that it is possible to clean internal parts which
have contained dangerous substances or preparations without entering them; any necessary unblocking must
also be possible from the outside. If it is absolutely impossible to avoid entering the machinery, the manu-
facturer or his authorised representative must take steps during its construction to allow cleaning to take place
with the minimum of danger.

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1.8.

Information, warnings and warning systems

1.8.1.

Information devices

The information needed to control machinery must be unambiguous and easily understood.

It must not be excessive to the extent of overloading the operator.

Where the health and safety of exposed persons may be endangered by a fault in the operation of unsupervised
machinery, the machinery must be equipped to give an appropriate acoustic or light signal as a warning.

1.8.2. Warning devices

Where machinery is equipped with warning devices, these must be unambiguous and easily perceived.

The operator must have facilities to check the operation of such warning devices at all times.

The requirements of the specific directives concerning colours and safety signals must be complied with.

1.8.3. Warning of residual risks

Where risks remain despite all the measures adopted or in the case of potential risks which are not evident,
the manufacturer or his authorised representative must provide warnings.

Such warnings should preferably use readily understandable pictograms and/or be drawn up in one of the
languages of the country in which the machinery is to be used, accompanied, on request, by versions in the
languages understood by the operators.

1.9.

Marking of machinery

All machinery must be marked legibly and indelibly with the following minimum particulars:

(cid:151) the name and address of the manufacturer and, where applicable, his authorised representative (1),

(cid:151) where applicable, the name and address of the natural or legal person who assumes responsibility for its

conformity to this Directive,

(cid:151) designation of the machinery,

(cid:151) CE marking,

(cid:151) designation of series or type,

(cid:151) serial number, if any,

(cid:151) the year of construction (2).

Furthermore, machinery designed and constructed for use in a potentially explosive atmosphere must be
marked accordingly.

Machinery must also bear full information relevant to its type and essential to its safe use.

Where a machine part must be handled during use with lifting equipment, its mass must be indicated legibly,
indelibly and unambiguously.

All the information must be clearly identifiable by the final user.

(1) Business name and full address; where the marking is established by the authorised representative, the business name and address of

the manufacturer must also be shown.

(2) The year of construction is the date with which the end of the manufacturing process must coincide stricto sensu. The EC declaration
of conformity must be established on that date. It is therefore formally prohibited to pre-date or post-date the machinery when
affixing the CE marking.

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1.10.

Instructions

Every machine must be accompanied by instructions in the official Community language(s) which may be
determined in accordance with the Treaty by the Member State in which it is placed on the market and/or put
into service.

The instructions accompanying the machine must be either (cid:145)Original instructions(cid:146) or a (cid:145)Translation of the
original instructions(cid:146), in which case the translation must be accompanied by the original instructions.

The instructions must be drafted in accordance with the principles set out below.

1.10.1. General principles on the drafting of instructions

(a) The contents of the instructions must be limited to the machine in question and cover not only the normal

use of the machinery but also uses which may reasonably be expected of it.

(b) The manufacturer or his authorised representative must draft the instructions in an official Community
language. The words (cid:145)Original
instructions(cid:146) should appear on the language version(s) verified by the
manufacturer. If the manufacturer or his authorised representative verify versions of the instructions in
instructions(cid:146).
other official Community languages, these versions should also bear the words (cid:145)Original

(c) Where no (cid:145)Original instructions(cid:146) exist in the official language(s) of the country where the machinery is to
be used, a translation into that/those language(s) must be made by the person introducing the machinery
into the language area in question. The translations must bear the words (cid:145)Translation of the original(cid:146).

(d) In the case of machinery which may be intended for use by non-professional operators, the wording and
layout of the instructions for use must take into account the level of general education and acumen that
can reasonably be expected from such operators.

(e) By way of exception, the maintenance instructions intended for use by specialist operators employed by the
manufacturer or his authorised representative may be drafted in only one Community language which the
operators understand.

1.10.2.

Contents of the instructions

Each instruction manual must contain the following information:

(a)

the name and address of the manufacturer and, where applicable, his authorised representative,

(b) the designation of the machinery as marked on the machinery itself, except for the serial number (see

section 1.9),

(c)

the installation and assembly instructions, including the means of attachment,

(d) the instructions for putting the machinery into service and, if necessary, training instructions,

(e) where appropriate, the essential characteristics of tools which may be fitted to the machinery,

(f)

instructions on the safety of handling operations, giving the mass of the machinery and its various parts
where they are regularly to be transported separately,

(g)

intended conditions of use of the machinery within the meaning of 1.1.2(c),

(h) where applicable, a statement that the machinery is intended for use in a potentially explosive atmosphere,

(i) workstation(s) likely to be occupied by operators,

(j)

the operating method to be followed in case of accident or breakdown. If a blockage is likely to occur, the
instructions are to specify the operating method to be followed to enable the equipment to be safely
deblocked,

(k) the definition of the adjustment and maintenance operations that should be carried out by the user and the

preventive measures that should be observed,

(l)

information to facilitate maintenance,

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(m) instructions on the connecting of fluids, including electrical connections, which may be the source of risk,

(n) ways in which the machinery should not be used,

(o) the obligation on the part of the user to comply with the provisions relating to the use of work equipment

and in particular Council Directive 89/655/EEC (1),

(p) conditions in which the machinery meets the requirement of stability during use, transportation, assembly,

dismantling, when out of service, during testing or during foreseeable breakdowns,

(q) the requirements relating to installation and assembly for reducing noise or vibration,

(r)

the following information on airborne noise emissions:

(cid:151) equivalent continuous A-weighted sound pressure level at workstations, where this exceeds 70 dB(A);

where this level does not exceed 70 dB(A), this fact must be indicated,

(cid:151) peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa

(130 dB in relation to 20 (cid:236)Pa),

(cid:151) sound power level emitted by the machinery where the equivalent continuous A-weighted sound

pressure level at workstations exceeds 85 dB(A).

These values must be either those actually measured for the machinery in question, or those established on the
basis of measurements taken for technically comparable machinery which is representative of the machinery to
be produced.

In the case of very large machinery, instead of the sound power level the equivalent continuous sound pressure
levels at specified positions around the machinery may be indicated.

Where the harmonised standards are not applied, sound levels must be measured using the most appropriate
method for the machinery.

The operating conditions of the machinery during measurement and the measuring methods used must be
described.

Where the workstation(s) are undefined or cannot be defined, sound pressure levels must be measured at a
distance of 1 metre from the surface of the machinery and at a height of 1.6 metres from the floor or access
platform. The position and value of the maximum sound pressure must be indicated.

Where specific directives lay down other requirements for the measurement of sound pressure levels or sound
power levels, those directives must be applied and the corresponding provisions of this section shall not apply.

2.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF
MACHINERY

Agri-foodstuffs machinery and machinery for the cosmetics and pharmaceuticals industries, hand-held and/or
hand-guided machinery and machinery for working wood and analogous materials must meet all the essential
health and safety requirements described in this annex. The following essential requirements therefore relate
only to the particular characteristics of these types of machinery.

2.1.

Agri-foodstuffs machinery and machinery for the cosmetics and pharmaceuticals industries

2.1.1.

General

Agri-foodstuffs machinery and machinery for the cosmetics and pharmaceuticals industries must be so
designed and constructed as to avoid any risk of infection, sickness or contagion.

The following hygiene rules must be observed:

(a) materials in contact, or intended to come into contact, with foodstuffs or cosmetic or pharmaceutical
products must satisfy the conditions set down in the relevant Directives. The machinery must be so
designed and constructed that these materials can be clean before each use;

(1) OJ L 393, 30 12.1989, p. 13, as amended by Directive 95/63/EC (OJ L 335, 30.12.1995, p. 28).

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(b) all surfaces in contact with foodstuffs or cosmetic or pharmaceutical products must:

(cid:151) be smooth, and must have neither ridges nor crevices which could harbour organic materials. The

same applies to their joinings;

(cid:151) be designed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum.

They should preferably be made by welding or continuous bonding;

(cid:151) be easily cleaned and disinfected, where possible after removing easily dismantled parts. The inside

surfaces must have curves of a radius sufficient to allow thorough cleaning;

(c) it must be possible to discharge liquids and gases deriving from foodstuffs or cosmetic or pharmaceutical
products, as well as cleaning, disinfecting and rinsing fluids from the machine, without impediment
(possibly in a (cid:145)clean(cid:146) position);

(d) machinery must be so designed and constructed as to prevent any liquids or living creatures, in particular

insects, entering, or any organic matter accumulating in areas that cannot be cleaned;

(e) machinery must be so designed and constructed that no ancillary substances, including the lubricants used,
can come into contact with foodstuffs or cosmetic or pharmaceutical products. Where necessary,
machinery must be designed and constructed so that continuing compliance with this requirement can
be checked.

2.1.2.

Instructions

The instructions for agri-foodstuffs machinery and machinery for the cosmetics and pharmaceuticals industries
must indicate recommended products and methods for cleaning, disinfecting and rinsing (not only for easily
accessible areas but also for areas to which access is impossible or inadvisable).

2.2.

Portable hand-held and/or hand-guided machinery

2.2.1.

General

Portable hand-held and/or hand-guided machinery must:

(cid:151) according to the type of machinery, have a supporting surface of sufficient size and a sufficient number of
handles and supports of an appropriate size and arranged to ensure the stability of the machinery under
the intended operating conditions;

(cid:151) except where technically impossible or where there is an independent control, in the case of handles which
cannot be released in complete safety, be fitted with manual whenever the machinery is about to start and
stop controls arranged in such a way that the operator can operate them without releasing the handles;

(cid:151) it must be designed, constructed or equipped to eliminate the risks of accidental starting and/or continued
operation after the operator has released the handles. Equivalent steps must be taken if this requirement is
not technically feasible;

(cid:151) it must be designed and constructed to allow, where necessary, a visual check of the contact of the tool

with the material being processed.

The handles of portable machinery must be designed and constructed in such a way as to make starting and
stopping straightforward.

2.2.2.

Instructions

The instructions must give the following information concerning vibrations transmitted by hand-held and
hand-guided machinery:

(cid:151) the weighted root mean square acceleration value to which the arms are subjected, if it exceeds 2.5 m/s2
as determined by the appropriate test code. Where the acceleration does not exceed 2.5 m/s2, this must be
mentioned.

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This value must be actually measured for the machinery in question, or determined on the basis of
measurements made on technically comparable machinery representing the intended production.

If harmonised standards are not applied, the vibration data must be measured using the most appropriate
measurement code for the machinery.

The operating conditions during measurement and the methods used for measurement must be described.

2.3.

Portable cartridge-operated fixing devices

2.3.1.

General

Portable cartridge-operated fixing devices must be designed and constructed in such a way that:

(cid:151) energy is transmitted from the cartridge to the projectile via an intermediary component and not by direct

action,

(cid:151) the device cannot be used unless it is positioned correctly and with adequate pressure on the workpiece,

(cid:151) the device cannot be triggered accidentally,

(cid:151) a shield can be used, if necessary.

Particular precautions must be taken to prevent the chamber from rupturing.

2.3.2.

Instructions

The instructions for a given device must give the necessary information regarding:

(cid:151) suitable cartridges;

(cid:151) interchangeable equipment that can be used.

2.4.

Machinery for working wood and analogous materials

Machinery for working wood and analogous materials must comply with the following rules:

(a) The machinery must be designed, constructed or equipped so that the piece being machined can be placed
and guided in safety; where the piece is hand-held on a work-bench the latter must be sufficiently stable
during the work and must not impede the movement of the piece.

(b) Where the machinery is likely to be used in conditions involving the risk of ejection of pieces of wood, it
must be designed, constructed, or equipped to eliminate this ejection, or, if this is not possible, so that the
ejection does not engender risks for the operator and/or exposed persons.

(c) The machinery must be equipped with an automatic brake that stops the tool in a sufficiently short time if

there is a risk of contact with the tool whilst it runs down.

(d) Where the tool is incorporated into a non-fully automated machine, the latter must be so designed and

constructed as to eliminate or reduce the risk of serious accidental injury.

3.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET THE HAZARDS DUE TO
THE MOBILITY OF MACHINERY

Machinery presenting hazards because of
the essential health and safety
requirements described in this annex. The following essential requirements therefore relate only to the
particular characteristics of this type of machinery.

its mobility must meet all

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3.1.

General

3.1.1.

Definitions

Machinery presenting hazards due to mobility:

(cid:151) machinery operated in working areas and whose operation requires either mobility while working, or

continuous or semi-continuous movement between a succession of fixed working locations;

(cid:151) machinery operated without being moved, but which may be equipped in such a way as to enable it to be

moved more easily from one place to another.

Driver: an operator responsible for the movement of a machine. The driver may be transported by the
machinery or may be on foot, accompanying the machinery, or may be guiding the machinery by remote
control.

3.1.2.

Lighting

If intended to be used in dark places or at night, self-propelled machinery must be fitted with a lighting device
appropriate to the work to be carried out, without prejudice to any other regulations applicable.

3.2.

Workstations

3.2.1.

Seating

Where machinery is fitted with provision for a rollover protection structure, the seat must be equipped with a
safety belt or equivalent device which keeps the driver in his seat without restricting any movements necessary
for driving or any movements relative to the structure caused by the suspension of the seat.

3.2.2.

Driving position

Visibility from the driving position must be such that the driver can, in complete safety for himself and the
exposed persons, operate the machinery and its tools in their intended conditions of use. Where necessary,
appropriate devices must be provided to remedy hazards due to inadequate direct vision.

Machinery must be so designed and constructed that, from the driving position, there can be no risk to the
driver and operators on board.

The driving position of ride-on drivers must be so designed and constructed that a driver’s cab may be fitted as
long as there is room. In that case, the cab must incorporate a place for the instructions needed for the driver
and/or operators.

3.2.3.

Other places

If the conditions of use provide that operators other than the driver may occasionally or regularly be trans-
ported by the machinery, or work on it, appropriate places must be provided which enable them to be
transported or to work on it without risk.

The second and third paragraphs of 3.2.2 also apply to the places for operators other than the driver.

3.3.

Controls

If necessary, steps must be taken to prevent unauthorised use of control points.

In the case of remote controls, each control point must clearly identify the machinery to be controlled from
that point.

The control system must be designed and constructed in such as way as to affect:

(cid:151) the machinery in question;

(cid:151) the functions in question.

Machinery must be designed and constructed in such as way that it will respond only to signals from the
intended control points.

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3.3.1. Manual controls

The driver must be able to actuate all manual controls required to operate the machinery from the driving
position, except for functions which can be safely actuated only by using manual controls located away from
the driving position. This refers in particular to working positions other than the driving position, for which
operators other than the driver are responsible or for which the driver has to leave his driving position in
order to carry out the manoeuvre in safety.

Where there are pedals they must be so designed, constructed and fitted to allow operation by the driver in
safety with the minimum risk of confusion; they must have a slip-resistant surface and be easy to clean.

Where their operation can lead to hazards, notably dangerous movements, the machinery’s manual controls,
except for those with preset positions, must return to the neutral position as soon as they are released by the
operator.

In the case of wheeled machinery, the steering system must be designed and constructed to reduce the force of
sudden movements of the steering wheel or steering lever caused by shocks to the guide wheels.

Any control that locks the differential must be so designed and arranged that it allows the differential to be
unlocked when the machinery is moving.

The penultimate subparagraph of 1.2.2 applies only in the case of reversing.

3.3.2.

Starting/moving

All travel movements of self-propelled machinery with a ride-on driver must be possible only if the driver is at
the controls.

Where, for operating purposes, machinery must be fitted with devices which exceed its normal clearance zone
(e.g. stabilisers, jib, etc.), the driver must be provided with the means of checking easily, before moving the
machinery, that such devices are in a particular position which allows safe movement.

This also applies to all other parts which, to allow safe movement, have to be in particular positions, locked if
necessary.

Where it is technically and economically feasible, movement of the machinery must depend on safe posi-
tioning of the aforementioned parts.

It must not be possible for movement of the machinery to occur while the engine is being started.

3.3.3.

Travelling function

Without prejudice to the provisions of road traffic regulations, self-propelled machinery and its trailers must
meet the requirements for slowing down, stopping, braking and immobilisation so as to ensure safety under all
the operating, loading, speed, ground and gradient conditions allowed for.

The driver must be able to slow down and stop self-propelled machinery by means of a main device. Where
safety so requires in the event of a failure of the main device, or in the absence of the energy supply to actuate
the main device, an emergency device with fully independent and easily accessible controls must be provided
for slowing down and stopping.

Where safety so requires, a parking device must be provided to render stationary machinery immobile. This
device may be combined with one of the devices referred to in the second paragraph, provided that it is purely
mechanical.

Remote-controlled machinery must be equipped with devices for stopping operation automatically and
immediately and for preventing potentially dangerous operation in the following situations:

(cid:151) if the driver loses control, except in the case of machines performing pre-programmed tasks outside the

remote-controlled zone when there is no possibility of a dangerous situation arising;

(cid:151) if it receives a stop signal;

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(cid:151) if a fault is detected in the system;

(cid:151) if no validation signal is detected within a specified time;

(cid:151) section 1.2.4.1 does not apply to the travelling function.

3.3.4. Movement of pedestrian-controlled machinery

Movement of pedestrian-controlled self-propelled machinery must be possible only through sustained action
on the relevant manual control by the driver. In particular, it must not be possible for movement to occur
while the engine is being started.

The control systems for pedestrian-controlled machinery must be designed to minimise the hazards arising
from inadvertent movement of the machine towards the driver, in particular:

(a) crushing;

(b) injury from rotating tools.

Also, the speed of normal travel of the machine must be compatible with the pace of a driver on foot.

In the case of machinery on which a rotary tool may be fitted, it must not be possible to actuate that tool
when the reversing control is engaged, except where movement of the machinery results from movement of
the tool. In the latter case, the reversing speed must be such that it does not endanger the driver.

3.3.5.

Control circuit failure

A failure in the power supply to the power-assisted steering, where fitted, must not prevent machinery from
being steered during the time required to stop it.

3.4.

Protection against mechanical hazards

3.4.1.

Uncontrolled movements

Machinery must be so designed, constructed and where appropriate placed on its mobile support so as to
ensure that, when moved, the uncontrolled oscillations of its centre of gravity do not affect its stability or exert
excessive strain on its structure.

3.4.2.

Rollover

Where, in the case of self-propelled machinery with a ride-on driver and possibly ride-on operators, there is a
risk of rolling over, the machinery must be designed and constructed to take account of this risk and be fitted
with anchorage points allowing it to be equipped with a rollover protective structure (ROPS).

This structure must be such that in case of rolling over it affords the ride-on driver and where appropriate the
ride-on operators an adequate deflection-limiting volume (DLV).

In order to verify that the structure complies with the requirement laid down in the second paragraph, the
manufacturer or his authorised representative must, for each type of structure concerned, perform appropriate
tests or have such tests performed.

In addition, the earth-moving machinery listed below with a capacity exceeding 15 kW must be fitted with a
rollover protective structure:

(cid:151) crawler loaders or wheel loaders,

(cid:151) backhoe loaders,

(cid:151) crawler tractors or wheel tractors,

(cid:151) scrapers, self-loading or not,

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(cid:151) graders,

(cid:151) articulated steer dumpers.

3.4.3.

Falling objects

Where, in the case of machinery with a ride-on driver and possibly ride-on operators, there is a risk due to
falling objects or material, the machinery should be designed and constructed to take account of this risk and
fitted, if its size allows, with anchorage points allowing it to be equipped with a falling-object protective
structure (FOPS).

This structure must be such that in the case of falling objects or material, it guarantees the ride-on operators
an adequate deflection-limiting volume (DLV).

In order to verify that the structure complies with the requirement laid down in the second paragraph, the
manufacturer or his authorised representative must, for each type of structure concerned, perform appropriate
tests or have such tests performed.

3.4.4. Means of access

Handholds and steps must be designed, constructed and arranged in such a way that the operators use them
instinctively and do not use the controls for that purpose.

3.4.5.

Towing devices

All machinery used to tow or to be towed must be fitted with towing or coupling devices designed,
constructed and arranged to ensure easy and safe connection and disconnection, and to prevent accidental
disconnection during use.

In so far as the towbar load requires, such machinery must be equipped with a support with a bearing surface
suited to the load and the ground.

3.4.6.

Transmission of power between self-propelled machinery (or tractor) and recipient machinery

Removable mechanical transmission components linking self-propelled machinery (or a tractor) to the first
fixed bearing of recipient machinery must be designed and constructed in such a way that any part that moves
during operation is protected over its whole length.

On the side of the self-propelled machinery (or tractor), the power take-off to which the removable mechanical
transmission component is attached must be guarded either by a screen fixed to the self-propelled machinery
(or tractor) or by any other device offering equivalent protection.

On the towed machinery side, the input shaft must be enclosed in a protective casing fixed to the machinery.

Torque limiters or freewheels may be fitted to universal joint transmissions only on the side adjoining the
driven machine. The removable mechanical transmission component must be marked accordingly.

All towed machinery whose operation requires a removable mechanical transmission component to connect it
to self-propelled machinery or a tractor must have a system for attaching the removable mechanical trans-
mission component so that, when the machinery is uncoupled, the removable mechanical transmission
component and its guard are not damaged by contact with the ground or part of the machinery.

The outside parts of the guard must be so designed, constructed and arranged that they cannot turn with the
removable mechanical transmission component. The guard must cover the transmission to the ends of the
inner jaws in the case of simple universal joints and at least to the centre of the outer joint or joints in the case
of (cid:145)wide-angle(cid:146) universal joints.

If means of access to working positions are provided near to the removable mechanical
transmission
component, they must be designed and constructed in such a way that the shaft guards cannot be used as
steps unless designed and constructed for that purpose.

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3.4.7. Moving transmission parts

By way of derogation from section 1.3.8.1, in the case of engines, removable guards preventing access to the
moving parts in the engine compartment need not have locking devices if they have to be opened either by
the use of a tool or key or by a control located in the driving position if the latter is in a fully enclosed cab
with a lock to prevent unauthorised access.

3.5.

Protection against other hazards

3.5.1.

Batteries

The battery housing must be designed and constructed so as to avoid as far as possible the chance of
electrolyte being ejected on to the operator in the event of rollover and/or to avoid the accumulation of
vapours in places occupied by operators.

Machinery must be so designed and constructed that the battery can be disconnected with the aid of an easily
accessible device provided for that purpose.

3.5.2.

Fire

Depending on the hazards anticipated by the manufacturer, machinery must, where its size permits:

(cid:151) either allow easily accessible fire extinguishers to be fitted,

(cid:151) or be provided with built-in extinguisher systems.

3.5.3.

Emissions of dust, gases etc.

The second and third paragraphs of section 1.6.14 do not apply where the main function of the machinery is
the spraying of products. The risk of the operator being exposed to emissions must, however, be minimised.

3.6.

Indications

3.6.1.

Signs and warning

All machinery must have means of signalling and/or instruction plates concerning use, adjustment and main-
tenance, wherever necessary, to ensure the health and safety of exposed persons. They must be chosen,
designed and constructed in such a way as to be clearly visible and indelible.

Without prejudice to the requirements to be observed for travelling on the public highway, machinery with a
ride-on driver must have the following equipment:

(cid:151) an acoustic warning device to alert exposed persons,

(cid:151) a system of light signals relevant to the intended conditions of use. The latter requirement does not apply

to machinery intended solely for underground working and having no electrical power,

(cid:151) where appropriate, there must be a connection between a trailer and a machine that presents risks due to

mobility.

Remote-controlled machinery which under normal conditions of use exposes persons to the hazards of impact
or crushing must be fitted with appropriate means to signal its movements or with means to protect exposed
persons against such hazards. The same applies to machinery which involves, when in use, the constant
repetition of a forward and backward movement on a single axis where the back of the machine is not
directly visible to the driver.

Machinery must be so constructed that the warning and signalling devices cannot all be disabled uninten-
tionally. Where this is essential for safety, such devices must be provided with the means to check that they are
in good working order and their failure must be made apparent to the operator.

Where the movement of machinery or its tools is particularly hazardous, signs on the machinery must be
provided to warn against approaching the machinery while it is working; the signs must be legible at a
sufficient distance to ensure the safety of persons who have to be in the vicinity.

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3.6.2. Marking

The following must be shown legibly and indelibly on all machinery:

(cid:151) nominal power expressed in kW,

(cid:151) mass in kg of the most usual configuration and, where appropriate:

(cid:151) maximum drawbar pull provided for at the coupling hook, in Newtons (N),

(cid:151) maximum vertical load provided for on the coupling hook, in Newtons (N).

3.6.3.

Instructions

3.6.3.1. V i b r a t i o n s

The instructions for machinery that transmits vibrations to the whole body or the upper limbs of the driver
must give the following information for the parts of the body concerned:

(cid:151) the weighted root mean square acceleration value to which the arms are subjected, if it exceeds 2,5 m/s2.

Should it not exceed 2,5 m/s2, this must be mentioned,

(cid:151) the weighted root mean square acceleration value to which the body (feet or posterior) is subjected, if it

exceeds 0,5 m/s2. Should it not exceed 0,5 m/s2, this must be mentioned.

These values must be actually measured for the machinery in question, or determined on the basis of
measurements made on technically comparable machinery representing intended production.

Where the harmonised standards are not applied, the vibration must be measured using the most appropriate
method for the machinery concerned.

The operating conditions during measurement and the methods used must be described.

3.6.3.2. M u l t i p l e u s e s

The instructions for machinery allowing several uses depending on the equipment used and the instructions
for the interchangeable equipment must contain the information necessary for safely assembling and using the
basic machinery and the interchangeable equipment that can be fitted.

4.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET THE PARTICULAR
HAZARDS DUE TO A LIFTING OPERATION

Machinery presenting hazards due to lifting operations must meet all
the essential health and safety
requirements described in this annex. The following essential requirements therefore relate only to the
particular characteristics of this type of machinery.

4.1.

General

4.1.1.

Definitions

(a) (cid:145)Lifting operation(cid:146): a movement of loads or persons necessitating, at a given moment, a change of level.

(b) (cid:145)Slinging device(cid:146): device used to enclose or hook an object and raise it by means of a motor.

(c) (cid:145)Separate lifting accessory(cid:146): a lifting accessory which helps to make up or use a slinging device.

(d) (cid:145)Guided load(cid:146): load where the total movement is made along rigid or flexible guides, whose position is

determined by fixed points.

(e) (cid:145)Working coefficient(cid:146): the arithmetic ratio between the load guaranteed by the manufacturer or his auth-
orised representative up to which a piece of lifting machinery or equipment or an accessory is able to hold
it and the maximum working load marked on the machinery, equipment or accessory or respectively.

(f)

(cid:145)Test coefficient(cid:146): means the arithmetic ratio between the load used to carry out the static or dynamic tests
on a piece of lifting machinery or equipment or an accessory and the maximum working load marked on
the piece of machinery or equipment or accessory.

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(g) (cid:145)Static test(cid:146): the test during which the machinery or the lifting accessory is first inspected and subjected to a
force corresponding to the maximum working load multiplied by the appropriate static test coefficient and
then re-inspected once the said load has been released to ensure no damage has occurred.

(h) (cid:145)Dynamic test(cid:146): the test during which the machinery or lifting accessory is operated in all its possible
configurations at maximum working load multiplied by the appropriate dynamic test coefficient with
account being taken of the dynamic behaviour of the machinery in order to check that the machinery
or the lifting accessory is functioning properly.

4.1.2.

Protection against mechanical hazards

4.1.2.1. M a c h i n e r y r u n n i n g o n g u i d e r a i l s a n d r a i l

t r a c k s

Machinery must be provided with devices which act on the guide rails or tracks to prevent derailment.

However, if derailment occurs despite such devices, or if there is a failure of a rail or of a running component,
devices must be provided which prevent the equipment, component or load from falling or the machine from
overturning.

4.1.2.2. M e c h a n i c a l s t r e n g t h

Machinery,
lifting accessories and removable components must be capable of withstanding the stresses to
which they are subjected, both in and, where applicable, out of use, under the installation and operating
conditions provided for and in all relevant configurations, with due regard, where appropriate, to the effects of
atmospheric factors and forces exerted by persons. This requirement must also be satisfied during transport,
assembly and dismantling.

Machinery and lifting accessories must be designed and constructed so as to prevent failure from fatigue or
wear, taking due account of their intended use.

The materials used must be chosen on the basis of the intended working environments, with special reference
to corrosion, abrasion, impacts, cold brittleness and ageing.

The machinery and the lifting accessories must be designed and constructed to withstand the overload in the
static tests without permanent deformation or patent defect. The calculation must take account of the values of
the static test coefficient chosen to guarantee an adequate level of safety; that coefficient has, as a general rule,
the following values:

(a) manually-operated machinery and lifting accessories: 1.5;

(b) other machinery: 1.25.

Machinery must be designed and constructed to undergo, without failure, the dynamic tests carried out using
the maximum working load multiplied by the dynamic test coefficient. This dynamic test coefficient is chosen
so as to guarantee an adequate level of safety: the coefficient is, as a general rule, equal to 1.1.

The static and dynamic tests must be performed on all machinery ready to be put into use.

As a general rule, the tests will be performed at the nominal speeds provided for. Should the control circuit of
the machinery allow for a number of simultaneous movements, the tests must be carried out under the least
favourable conditions, i.e. as a general rule, by combining the movements concerned.

4.1.2.3. L i f t i n g a c c e s s o r i e s

Pulleys, drums and wheels must have a diameter commensurate with the size of ropes or chains with which
they can be fitted.

Drums and wheels must be so designed, constructed and installed that the ropes or chains with which they are
equipped can wind round without falling off.

Ropes used directly for lifting or supporting the load must not include any splicing other than at their ends.
Splicings are, however, tolerated in installations which are intended from their design to be modified regularly
according to needs of use.

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Complete ropes and their endings have a working coefficient chosen so as to guarantee an adequate level of
safety; as a general rule, this coefficient is equal to five.

Lifting chains have a working coefficient chosen so as to guarantee an adequate level of safety; as a general
rule, this coefficient is equal to four.

In order to verify that an adequate working coefficient has been attained, the manufacturer or his authorised
representative must, for each type of chain and rope used directly for lifting the load, and for the rope ends,
perform the appropriate tests or have such tests performed.

4.1.2.4. S e p a r a t e l i f t i n g a c c e s s o r i e s

Lifting accessories must be sized with due regard to fatigue and ageing processes for a number of operating
cycles consistent with their expected life-span as specified in the operating conditions for a given application.

Moreover:

(a) the working coefficient of the wire-rope/rope-end combination is chosen so as to guarantee an adequate
level of safety; this coefficient is, as a general rule, equal to five. Ropes must not comprise any splices or
loops other than at their ends,

(b) where chains with welded links are used, they must be of the short-link type. The working coefficient of
chains of any type is chosen so as to guarantee an adequate level of safety; this coefficient is, as a general
rule, equal to four,

(c) the working coefficient for textile ropes or slings is dependent on the material, method of manufacture,
dimensions and use. This coefficient is chosen so as to guarantee an adequate level of safety; it is, as a
general rule, equal to seven, provided the materials used are shown to be of very good quality and the
method of manufacture is appropriate to the intended use. Should this not be the case, the coefficient is, as
a general rule, set at a higher level in order to secure an equivalent level of safety.

Textile ropes and slings must not include any knots, connections or splicing other than at the ends of the
sling, except in the case of an endless sling,

(d) all metallic components making up, or used with, a sling must have a working coefficient chosen so as to

guarantee an adequate level of safety; this coefficient is, as a general rule, equal to four,

(e) the maximum working capacity of a multilegged sling is determined on the basis of the safety coefficient of
the weakest leg, the number of legs and a reduction factor which depends on the slinging configuration,

(f)

in order to verify that an adequate working coefficient has been attained, the manufacturer or his auth-
orised representative must, for each type of component referred to in (a), (b), (c) and (d) perform the
appropriate tests or have such tests performed.

4.1.2.5. C o n t r o l o f m o v e m e n t s

Devices for controlling movements must act in such a way that the machinery on which they are installed is
kept safe.

(a) Machinery must be designed and constructed or fitted with devices so that the amplitude of movement of
its components is kept within the specified limits. The operation of such devices must, where appropriate,
be preceded by a warning.

(b) Where several fixed or rail-mounted machines can be manoeuvred simultaneously in the same place, with
risks of collision, such machines must be so designed and constructed as to make it possible to fit systems
enabling these risks to be avoided.

(c) Machinery must be so designed and constructed that the loads cannot creep dangerously or fall freely and
unexpectedly, even in the event of partial or total failure of the power supply or when the operator stops
operating the machine.

(d) It must not be possible, under normal operating conditions, to lower the load solely by friction brake,

except in the case of machinery whose function requires it to operate in that way.

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(e) Holding devices must be so designed and constructed that inadvertent dropping of the loads is avoided.

4.1.2.6. M o v e m e n t o f

l o a d s d u r i n g h a n d l i n g

The driving position of machinery must be located in such a way as to ensure the widest possible view of
trajectories of the moving parts, in order to avoid possible collisions with persons or equipment or other
machinery which might be manoeuvring at the same time and liable to constitute a hazard.

Machinery with guided loads and machinery whose load supports follow a clearly defined path must be
designed, constructed and equipped with devices to prevent any risks to exposed persons.

4.2.

Special requirements for machinery whose power source is other than manual effort

4.2.1. Movement controls

Hold-to-run control devices must be used to control the movements of the machinery or its equipment.
However, for partial or complete movements in which there is no risk of the load or the machinery colliding,
the said devices may be replaced by actuators authorising automatic stops at preselected levels without the
operator holding a hold-to-run control device.

4.2.2.

Loading control

Machinery with a maximum working load of not less than 1 000 kg or an overturning moment of not less
than 40 000 Nm must be fitted with devices to warn the driver and prevent dangerous movements in the
event of:

(cid:151) overloading the machinery:

(cid:151) either as a result of maximum working loads being exceeded, or,

(cid:151) as a result of the moments due to the loads being exceeded,

(cid:151) the moments conducive to overturning being exceeded.

4.2.3.

Cables for installations guided by cables

Cable carriers, tractors or tractor carriers must be held by counter-weights or by a device allowing permanent
control of the tension.

4.2.4.

Risks to exposed persons

Machinery serving specific levels at which operators can gain access to the load platform in order to stack or
secure the load must be designed and constructed to prevent uncontrolled movement of the load platform, in
particular while being loaded or unloaded.

4.3.

Marking

4.3.1.

Chains and rope

Each length of lifting chain, rope or webbing not forming part of an assembly must bear, in addition to the CE
marking, a mark showing the name and address of the manufacturer or his authorised representative and the
identifying reference of the relevant certificate.

If it is not physically possible to show all or part of the information required for lifting accessories, this
information must be given on a plate or irremovable ring, or by other means firmly attached to the accessory.

The particulars must be legible, indelible and located in a place where they are not likely to adversely affect the
strength of the accessory.

The certificate mentioned above should show the information required by the harmonised standards or, should
those not exist, at least the following information:

(cid:151) the name and address of the manufacturer and, if appropriate, his authorised representative,

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(cid:151) a description of the chain or rope which includes:

(cid:151) its nominal size,

(cid:151) its construction,

(cid:151) the material from which it is made, and,

(cid:151) any special metallurgical treatment applied to the material,

(cid:151) if tested, the standard used,

(cid:151) the maximum load to which the chain or rope should be subjected in service. A range of values may be

given on the basis of the intended applications.

4.3.2.

Lifting accessories

All lifting accessories not forming part of an assembly must bear the following marks:

(cid:151) identification of the material where this information is needed for dimensional compatibility,

(cid:151) identification of the maximum working load,

(cid:151) CE marking.

4.3.3.

Lifting machinery

Each machine must bear, legibly and indelibly, information concerning the maximum load:

(a) displayed in uncoded form and prominently in the case of machinery which has only one possible value;

(b) where the nominal

load depends on the configuration of the machine, each driving position must be
provided with a load plate indicating, preferably in diagrammatic form or by means of tables, the nominal
loads for each configuration.

Machinery equipped with a load support which allows access for persons and involves a risk of falling must
bear a clear and indelible warning prohibiting the lifting of persons. This warning must be visible at each place
where access is possible.

4.4.

Instructions

4.4.1.

Lifting and separate lifting accessories

Each lifting accessory or each commercially indivisible batch of lifting accessories must be accompanied by
instructions setting out at least the following particulars:

(cid:151) normal conditions of use,

(cid:151) the test coefficients,

(cid:151) instructions for use, assembly and maintenance,

(cid:151) the limits of use (particularly for accessories such as magnetic or pneumatic pads which cannot comply

with 4.1.2.5(e)).

4.4.2.

Lifting machinery

All machinery must be accompanied by instructions containing information on:

(a) the technical characteristics of the machinery, and in particular:

(cid:151) where appropriate, a copy of the load table described in section 4.3.3.(b),

(cid:151) the reactions at the supports or anchors and, where appropriate, characteristics of the tracks,

(cid:151) where appropriate, the definition and the means of installation of the ballast;

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(b) the contents of the logbook, if the latter is not supplied with the machinery;

(c) advice for use, particularly to offset the lack of direct sight of the load by the operator;

(d) the necessary instructions for performing the tests before first putting into service machinery which is not
assembled on the premises of the manufacturer or his authorised representative in the form in which it is
to be used.

5.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY INTENDED FOR
UNDERGROUND WORK

Machinery intended for underground work must meet all the essential health and safety requirements described
in this annex. The following essential requirements therefore relate only to the particular characteristics of this
type of machinery.

5.1.

Risks due to lack of stability

Powered roof supports must be so designed and constructed as to maintain a given direction when moving
and not slip before and while they come under load and after the load has been removed. They must be
equipped with anchorages for the top plates of the individual hydraulic props.

5.2.

Movement

Powered roof supports must allow for unhindered movement of exposed persons.

5.3.

Lighting

The requirements laid down in section 1.1.5 do not apply.

5.4.

Manual controls

The accelerator and brake controls for the movement of machinery running on rails must be manual. The
deadman’s control may be foot-operated, however.

The manual controls of powered roof supports must be designed and laid out so that, during displacement
operations, operators are sheltered by a support in place. The manual controls must be protected against any
accidental release.

5.5.

Stopping

Self-propelled machinery running on rails for use in underground work must be equipped with a deadman’s
control acting on the circuit controlling the movement of the machinery.

5.6.

Fire

The second indent of 3.5.2 is mandatory in respect of machinery which comprises highly flammable parts.

The braking system of machinery meant for use in underground working must be designed and constructed so
as not to produce sparks or cause fires.

Machinery with heat engines for use in underground working must be fitted only with internal combustion
engines using fuel with a low vaporising pressure and which exclude any spark of electrical origin.

5.7.

Emissions of gases

Exhaust gases from internal combustion engines must not be discharged upwards.

6.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY PRESENTING
PARTICULAR HAZARDS DUE TO THE LIFTING OR MOVING OF PERSONS

Machinery presenting hazards due to the lifting or moving of persons must meet all the essential health and
safety requirements described in this annex. The following essential requirements therefore relate only to the
particular characteristics of this type of machinery.

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6.1.

General

6.1.1.

Definition

(cid:145)Carrier(cid:146): the device by which persons are supported in order to be lifted, lowered or moved.

6.1.2. Mechanical strength

The working coefficients defined in heading 4 are inadequate for machinery intended for the lifting or moving
of persons and must, as a general rule, be doubled. The floor of the carrier must be designed and constructed
to offer the space and strength corresponding to the maximum number of persons and the maximum working
load.

6.1.3.

Loading control for types of device moved by power other than human strength

The requirements of 4.2.2 apply regardless of the maximum working load and the moment conducive to
overturning.

6.2.

Manual controls

Where safety requirements do not impose other solutions, the carrier must, as a general rule, be designed and
constructed so that persons inside have means of controlling movements upwards and downwards and, if
appropriate, of moving the carrier horizontally in relation to the machinery.

In operation, those controls must override the other devices controlling the same movement, with the
exception of the emergency stop devices.

The controls for these movements must be of the hold-to-run type.

6.3.

Risks to persons in the carrier

6.3.1.

Risks of persons falling from the carrier

Where work is performed from the carrier, special precautions must be taken to ensure stability and prevent
sudden movements.

If the measures referred to in 1.6.16 are not adequate, carriers must be fitted with a sufficient number of
anchorage points for the number of persons possibly using the carrier, strong enough for the attachment of
personal protective equipment against the danger of falling.

Any trapdoors in floors or ceilings or side doors must open in a direction which obviates any risk of falling
should they open unexpectedly.

Machinery for lifting or moving must be designed and constructed to ensure that the floor of the carrier does
not tilt to an extent which creates a risk of the occupants falling, including when moving.

The floor of the carrier must be slip-resistant.

6.3.2.

Risks of the carrier falling or overturning

The machinery must be designed and constructed to prevent the carrier falling or overturning.

Machinery for lifting or transporting persons must be designed, constructed or equipped in such a way that
the acceleration or deceleration of the carrier does not engender risks for exposed persons. It must be fitted
with handles that are fixed relative to the users and that enable them to maintain their stability.

If machinery for the lifting or moving of persons can be moved with the carrier in a position other than the
rest position, it must be designed and constructed so that the person or persons in the carrier have the means
of preventing hazards which may be produced by the movement of the machinery.

6.4.

Markings

Where necessary to ensure safety, the carrier must bear the relevant essential information.

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7.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY PRESENTING
PARTICULAR HAZARDS DUE TO LIFTING OPERATIONS AND INTENDED FOR PERSONS WITH
REDUCED MOBILITY

Machinery presenting particular hazards due to lifting operations and intended for persons with reduced
mobility must meet all the essential health and safety requirements described in this annex. The following
essential requirements therefore relate only to the particular characteristics of these types of machinery.

7.1.

Definitions

For the purposes of this chapter,
(cid:145)support(cid:146) means any device by which persons of reduced mobility are
supported in order to enable them to change level. Supports include platforms, seats or any other device
performing the same function.

7.2.

Manual controls

The manual controls must be designed and constructed so as to be easily accessible to users, taking account of
their handicap.

When a support is bearing a person, the controls must be of the hold-to-run type and must override all other
controls. This requirement does not apply to the function of calling a support from a landing.

7.3.

Falling of the support

Machinery must be equipped with devices to prevent free falling or uncontrolled upward movements of the
support. The device to prevent free falling of the support must be independent of the support’s suspension.

load and at the maximum speed
This device must be capable of stopping the support under its nominal
provided for by the installer. The stopping action must not, irrespective of the load, cause deceleration that is
dangerous for the occupants.

Measures must be taken to prevent the support from knocking into the ends of the enclosure.

7.4.

Access to the support

Machinery must be designed and constructed so as to minimise the difference in level between the support and
each of the levels served.

The approaches to the support must be equipped with protection devices in order to prevent the risk of
people falling when the support is not at a landing.

These protection devices must be equipped with an interlocking device controlled by the position of the
support so that:

(cid:151) they cannot be opened unless the support is present,

(cid:151) the support cannot move until the protection device has been closed.

If the possible vertical drop is less than 0.50 m, a railing is sufficient.

If the possible vertical drop is between 0.50 m and 3 m, the doors and fixed walls protecting the travel zone
must be unperforated and at least 1.10 m high,

If the possible vertical drop is more than 3 m, there must be a landing entrance and the fixed walls protecting
the travel zone must be unperforated and at least 2 m high.

8.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CONSTRUCTION SITE HOISTS
INTENDED FOR LIFTING PERSONS OR PERSONS AND GOODS

Construction site hoists intended for lifting persons or persons and goods must meet all the essential health
and safety requirements described in this annex. The following essential requirements therefore relate only to
the particular characteristics of these types of machinery.

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8.1.

Cab

Construction site hoists intended for lifting persons or persons and goods must be fitted with an enclosed cab;
the walls and roof of the cab may be perforated or unperforated.

Where, for construction site hoists intended for lifting persons or persons and goods, there is a risk of objects
falling and endangering persons, the roof of the cab must be suitably protected.

8.2.

Protection of the travel zone of the cab

The zone through which the cab travels should not be accessible during normal operation.

8.3.

Suspension system for the load support

Construction site hoists intended for lifting persons or persons and goods must be fitted with a suspension
system for the load support, fixings and end pieces designed and constructed in such a way as to ensure an
adequate overall level of safety and to minimise the risk of the load support falling.

If cables or chains are used to suspend the load support, at least two independent cables or chains are required,
each with its own anchorage. Except when a loop is necessary, the cables or chains must not comprise any
knots or splices.

8.4.

Falling of the load support

Construction site hoists intended for lifting persons or persons and goods must be fitted with devices to
prevent free falling or uncontrolled upward movements of the load support. The device to prevent free falling
of the load support must be independent of the load support’s suspension.

This device must be capable of stopping the load support under its nominal load and at the maximum speed
provided for. The stopping action must not, irrespective of the load, cause deceleration that is dangerous for
the occupants.

Measures must be taken to prevent the support knocking into the ends of the enclosure.

8.5.

Access to the load support

Construction site hoists intended for lifting persons or persons and goods must be designed and constructed so
as to minimise the difference in level between the load support and each of the levels served.

The approaches to the load supports must be equipped with an interlocking device controlled by the position
of the load support so that:

(cid:151) they cannot be opened unless the support is present,

(cid:151) the support cannot move until the protection device has been closed.

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ANNEX II

CONTENTS OF DECLARATIONS

A. Contents of the EC declaration of conformity of the machine (1)

The EC declaration of conformity (2) must contain the following particulars:

1. name and address of the manufacturer or his authorised representative (3),

2. name and address of the person who is authorised to compile the technical file, who must be established in the

Community,

3. description and identification of the machine (4),

4. a declaration of conformity with the present Directive,

5. where appropriate, a declaration of conformity with other European Directives (5) and/or relevant provisions

with which the machine complies,

6. where appropriate, the name, address and identification number of the notified body which carried out the
procedure for ensuring that the machine complies with the harmonised standards provided for in Annex IX,

7. where appropriate, the name, address and identification number of the notified body and the number of the EC

type-examination certificate provided for in Annex X,

8. where appropriate, the name, address and identification number of the notified body which provided the full

quality assurance provided for in Annex XI,

9. where appropriate, a reference to the harmonised standards used,

10. where appropriate, the national technical standards and specifications used,

11.

the place and date of the declaration,

12. the identity and signature of the manufacturer or his authorised representative or of the person empowered to

draw up the declaration.

B. Contents of the declaration of incorporation of partly completed machinery (6)

The declaration of incorporation must contain the following particulars:

1. name and address of the manufacturer of the partly completed machinery (7) or his authorised representative,

2. description and identification of the partly completed machinery (8),

3. where appropriate, a declaration of the conformity of the partly completed machinery with other relevant

European Directives (9),

(1) This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex 1, point

1.10.1.(c), and must be either typewritten or handwritten in block capitals.

(2) This declaration relates exclusively to the machine in the state in which it was delivered, and excludes components which are added

and/or operations carried out subsequently by the final user.

(3) Business name and full address; if the declaration is compiled by an authorised representative, the manufacturer’s business name and

address must also be given.

(4) A description of the machine, type, serial number, commercial name, etc.
(5) These references must be the ones published in the Official Journal of the European Communities.
(6) This declaration of incorporation must be either typewritten or handwritten in block capitals.
(7) Business name and full address; if the declaration is compiled by an authorised representative, the manufacturer’s business name and

address must also be given.

(8) A description of the partly completed machinery, type, serial number, commercial name, etc.
(9) These references must be the ones published in the Official Journal of the European Communities.

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4. an undertaking to transmit, in response to a reasoned request by the national authorities, relevant information on
the partly completed machinery. This shall include the method of transmission and shall be without prejudice to
the intellectual property rights of the manufacturer of the partly completed machinery,

5. a statement that the machinery must not be put into service until the machinery into which it is to be incor-

porated has been declared in conformity with the provisions of this Directive,

6. the place and date of the declaration,

7.

the identity and signature of the manufacturer or his authorised representative or of the person empowered to
draw up the declaration.

ANNEX III

CE MARKING

The CE conformity marking shall consist of the initials (cid:145)CE(cid:146) taking the following form:

If the CE marking is reduced or enlarged the proportions shown in the above drawing must be respected.

The various components of the CE marking must have substantially the same vertical dimension, which may not be less
than 5 mm. The minimum dimension may be waived for small-scale machinery.

The CE marking must be affixed in the immediate vicinity of the name of the manufacturer or his authorised
representative, as required in point 1.9 of Annex I, and be applied using the same technique.

ANNEX IV

TYPES OF MACHINERY TO WHICH ONE OF THE PROCEDURES REFERRED TO IN ARTICLE 12(4) AND (5)
MUST BE APPLIED

1.

Circular saws (single or multi-blade) for working with wood and analogous materials or for working with meat and
analogous materials.

1.1. Sawing machines with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the

workpiece or with a demountable power feed.

1.2. Sawing machines with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or

carriage.

1.3. Sawing machines with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces,

with manual loading and/or unloading.

1.4. Sawing machines with movable blade(s) during cutting, having a mechanical feed device for the workpieces, with

manual loading and/or unloading.

2. Hand-fed surface planing machines for woodworking.

3.

4.

Thicknessers for one-side dressing having a built-in feed mechanical feed device, with manual
unloading for woodworking.

loading and/or

Band-saws with manual loading and/or unloading for working with wood and analogous materials or for working
with meat and analogous materials.

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4.1. Sawing machines with fixed blade during cutting having a fixed or reciprocating-movement bed or support for the

workpiece.

4.2. Sawing machines with blade assembled on a carriage with reciprocating motion.

5.

Combined machines of the types referred to in points 1 to 3 and in point 7 for working with food and analogous
materials.

6. Hand-fed tenoning machines with several tool holders for woodworking.

7. Hand-fed vertical spindle moulding machines for working with wood and analogous materials.

8.

9.

Portable chainsaws for woodworking.

Presses, including press-brakes, for the cold working of metals, with manual
movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.

loading and/or unloading, whose

10.

Injection or compression plastics-moulding with manual loading or unloading.

11.

Injection or compression rubber-moulding machines with manual loading or unloading.

12. Machinery for underground working of the following types:

(cid:151) locomotives and brake-vans,

(cid:151) hydraulic-powered roof supports.

13. Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.

14. Removable mechanical transmission shafts.

15. Guards for removable mechanical transmission shafts.

16. Vehicle servicing lifts.

17. Devices for the lifting of persons or of persons and goods involving a risk of falling from a vertical height of more

than three metres.

18. Portable cartridge-operated fixing devices.

19. Electro-sensitive devices designed to detect persons (non-material barriers, sensor mats, electromagnetic detectors,

etc.).

20. Automatic mobile screens for protecting the machines referred to in points 9, 10 and 11.

ASSEMBLY INSTRUCTIONS FOR PARTLY COMPLETED MACHINERY

ANNEX V

These instructions must contain a description of the conditions which must be met with a view to correct incorporation
in the final machine, so as not to compromise human safety and health.

They must be written in an official Community language acceptable to the manufacturer of the machine in which the
partly completed machinery will be assembled, or to his authorised representative.

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ANNEX VI

TECHNICAL FILE FOR MACHINERY

1. This annex must describe the procedure for compiling a technical file. The technical file must demonstrate that the
machine complies with the requirements of the Directive. It must cover the design, manufacture and operation of the
machine to the extent necessary for this assessment. The technical file must be compiled in one of the official
languages of the Community, except for the instructions for the machine, for which the special provisions of Annex
I, point 1.10.1 apply.

The technical file shall comprise the following:

(a) a construction file including:

(cid:151) the overall drawing of the machine and drawings of the control circuits,

(cid:151) full detailed drawings, accompanied by any calculation notes,

test results, etc., required to check the

conformity of the machine with essential safety and health requirements,

(cid:151) a list of:

(cid:151) the essential health and safety requirements of this Directive which apply to the machine in question,

(cid:151) the standards and other technical specifications which were used,

(cid:151) a description of methods adopted to eliminate hazards presented by the machine,

(cid:151) any technical report or certificate obtained from a body or laboratory selected by the manufacturer or his

authorised representative,

(cid:151) if a harmonised standard which requires a technical report is used, any technical report giving the results of
the tests carried out either by the manufacturer or by a body or laboratory chosen by the manufacturer or his
authorised representative,

(cid:151) a copy of the instructions for the machine;

(b) for series manufacture, the internal measures that will be implemented to ensure that the machines remain in

conformity with the provisions of the Directive.

The manufacturer must carry out necessary research and tests on components, fittings or the completed machine
to determine whether by its design or construction it is capable of being assembled and put into service safely.

2. The technical file referred to in point 1 must be made available to the competent authorities of the Member States.

This technical file does not have to be located in the territory of the European Union, not does it have to be
permanently available in material form. It must be capable of being assembled and made available within a period of
time commensurate with its importance by the person designated in the EC declaration of conformity.

3. Failure to present the technical file in response to a duly substantiated request by the competent national authorities
may constitute sufficient grounds for doubting the presumption of conformity of the machinery referred to in this
technical file with the requirements of this Directive.

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ASSESSMENT OF CONFORMITY WITH INTERNAL CHECKS ON THE MANUFACTURE OF MACHINERY

1. This annex describes the procedure by which the manufacturer or his authorised representative, before placing the

ANNEX VII

machine on the market:

(cid:151) compiles a technical file,

(cid:151) draws up an EC declaration of conformity for each machine,

(cid:151) affixes the CE marking on each machine.

2. For each representative example of the series in question, the manufacturer or his authorised representative shall

draw up the technical file referred to in Annex VI, point 1.

3. The manufacturer or his authorised representative shall affix the CE marking described in Annex III on each machine
and shall, for each machine, draw up an EC declaration of conformity, the components of which are set out in Annex
II, part A.

The manufacturer or his authorised representative shall keep the technical file described in Annex VI, point 1,
together with a copy of the EC declaration of conformity, for a period of at least ten years from the last date of
manufacture of the machine.

For series manufacture of identical machines, a copy of the technical file representative of the series in question shall
suffice.

ANNEX VIII

ASSESSMENT OF CONFORMITY FOR A MACHINE NOT PRESENTING ANY INTRINSIC RISK TO SAFETY
OR HEALTH

Where the analysis of risks performed by the manufacturer or his authorised representative in accordance with Annex I
demonstrates that the Directive has no relevance in terms of safety and health, the following procedure shall be applied:

1. The manufacturer or his authorised representative shall affix the CE marking on each machine.

2. The manufacturer or his authorised representative shall keep the risk analysis for a period of ten years from the date
of manufacture of the machine or, in the case of series production, of the last machine manufactured. This analysis
must be kept available for inspection by the competent national authorities of the Member States.

3. There shall not be any requirement to compile an EC declaration of conformity or keep a complete technical file.

ANNEX IX

ADEQUACY IN RESPECT OF THE HARMONISED STANDARDS FOR MACHINERY REFERRED TO IN
ANNEX IV

1. This annex describes the conformity assessment for a machine referred to in Annex IV and manufactured in

accordance with one or more harmonised standards. It describes the procedure by which:

(cid:151) the manufacturer or his authorised representative, before placing the machine on the market:

(cid:151) compiles the technical file referred to in Annex VI, point 1,

(cid:151) lodges an application for approval of this technical file with a notified body,

(cid:151) the notified body:

(cid:151) ascertains and certifies that the technical file satisfies the provisions of this Directive,

(cid:151) draws up a certificate of adequacy,

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(cid:151) the manufacturer or his authorised representative, before placing the machine on the market:

(cid:151) draws up an EC declaration of conformity for each machine,

(cid:151) affixes the CE marking on each machine.

2. Before taking any other action, the manufacturer or his authorised representative must, for each representative

example of the series in question, draw up the technical file referred to in Annex VI, point 1.

3. The application for a certificate of adequacy shall be lodged by the manufacturer or his authorised representative

with a notified body of its choice, for each representative example of the series in question.

Files and correspondence concerning the inspection procedures by the notified body shall be written in an official
language of the Member State in which the notified body is established or in a language acceptable to it.

The application must contain:

(cid:151) the name and address of the manufacturer or his authorised representative,

(cid:151) a written declaration that the application has not been lodged with another notified body,

(cid:151) the technical file referred to in Annex VI, point 1.

4. The notified body shall examine the technical file and ascertain whether the harmonised standards which are referred

to in it have been applied correctly.

5. If the technical file satisfies the provisions of the Directive, the notified body shall

issue the applicant with a
certificate of adequacy. The certificate shall include the name and address of the manufacturer or his authorised
representative, the data necessary for identifying the machine described in the file, the conclusion of the examination
and the conditions to which its issue may be subject.

The notified body shall retain a copy of the certificate, the technical file and all other relevant documents for a period
of 15 years from the date of the issue of the certificate.

6. If it refuses to issue the manufacturer or his authorised representative with a certificate of adequacy, the notified body
shall give detailed reasons for the refusal. It shall inform the applicant and the other notified bodies accordingly. An
appeal procedure must be available.

If it withdraws a certificate of adequacy from the manufacturer or his authorised representative, the notified body
shall give detailed reasons for the withdrawal. It shall inform the applicant and the Member State which notified it,
inform the Commission and the other Member States. An appeal
stating the reasons for its decision. It shall
procedure must be available.

7. The applicant shall inform the notified body which retains the technical file relating to the certificate of adequacy of
all modifications to the approved machine. The notified body shall examine these modifications and either confirm
the validity of the existing certificate or issue a new one if the modifications are liable to compromise conformity
with the essential health and safety requirements or with the intended conditions of use of the machine.

8. The Commission, Member States and the other approved bodies may obtain, on request, a copy of the certificates of
adequacy. On reasoned request, the Commission and Member States may obtain a copy of the technical file and the
results of the examinations carried out by the notified body.

9. On receipt of the certificate of adequacy, the manufacturer or his authorised representative shall ensure and certify
that the machines manufactured in accordance with the technical file are in conformity with it and satisfy the
provisions of this Directive.

The manufacturer or his authorised representative shall affix the CE marking described in Annex III on each machine
and shall, for each machine, draw up an EC declaration of conformity, the components of which are set out in Annex
II, part A.

The manufacturer or his authorised representative shall, for each machine manufactured, retain the components of
the technical file, together with a copy of the EC declaration of conformity, for a period of at least ten years from the
last date of manufacture of the machine.

For series manufacture of identical machines, a copy of the technical file representative of the series in question shall
suffice.

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EC TYPE-EXAMINATION OF A MACHINE REFERRED TO IN ANNEX IV

ANNEX X

1.

This annex describes the conformity assessment of a machine referred to in Annex IV following a type-examination
performed by a notified body. It describes the procedure by which:

(cid:151) the manufacturer or his authorised representative, before placing the machine on the market

(cid:151) compiles the technical file referred to in Annex VI, point 1,

(cid:151) lodges an application for a type-examination with a notified body,

(cid:151) the notified body

(cid:151) ascertains and declares that a representative example of the series in question satisfies the provisions of this

Directive,

(cid:151) draws up an EC type-examination certificate,

(cid:151) the manufacturer or his authorised representative, before placing the machine on the market

(cid:151) draws up an EC declaration of conformity for each machine,

(cid:151) affixes the CE marking on each machine.

2. Before taking any other action, the manufacturer or his authorised representative must, for each specimen represen-

tative of the series in question, draw up the technical file referred to in Annex VI, point 1.

3.

For each example representative of the series in question, the application for an EC type-examination shall be
submitted by the manufacturer or his authorised representative to a notified body of its choice.

Files and correspondence referring to the type-examination procedures of the notified body shall be written in an
official language of the Member State where the notified body is established or in a language acceptable to it.

The application shall include:

(cid:151) the name and address of the manufacturer or his authorised representative,

(cid:151) a written declaration that the application has not been lodged with another notified body,

(cid:151) the technical file described in Annex VI, point 1.

Moreover, the applicant shall place at the disposal of the notified body an example which is representative of the
series in question, hereafter named the (cid:145)type(cid:146) (1). The notified body may ask for further copies if the test programme
so requires.

4. The notified body shall:

4.1. examine the technical file, check that the type was manufactured in accordance with it and establish which
components have been designed in accordance with the relevant provisions of the standards referred to in
Article 7(2), and those components whose design is not based on the relevant provisions of those standards;

4.2. carry out or have carried out appropriate inspections and tests to ascertain whether the solutions adopted satisfy
the essential health and safety requirements of the Directive where the standards referred to in Article 7(2) were not
applied;

4.3. where harmonised standards were used, carry out or have carried out appropriate inspections and tests to verify

that those standards were actually applied;

4.4. agree with the applicant as to the place where the necessary inspections and tests will be carried out.

(1) The type may comprise several versions of the machine in so far as the differences between those versions do not affect the level of

safety or other performance-related requirements of the machine.

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5.

If the type satisfies the provisions of the Directive, the notified body shall issue the applicant with an EC type-
examination certificate. The certificate shall include the name and address of the manufacturer or his authorised
representative, the data necessary for identifying the approved type, the conclusions of the examination and the
conditions to which its issue may be subject.

The notified body shall retain a copy of this certificate, the technical file and all relevant documents, for a period of
15 years from the date of issue of the certificate.

6.

If it refuses to issue the manufacturer or his authorised representative with an EC type-examination certificate, the
notified body shall give detailed reasons for its refusal. It shall inform the applicant and the other notified bodies.
An appeal procedure must be available.

If it withdraws an EC type-examination certificate from the manufacturer or his authorised representative, the
notified body shall give detailed reasons for the withdrawal. It shall inform the applicant and the Member State
which notified it, stating the reasons for its decision. This Member State shall inform the other Member States and
the Commission. An appeal procedure must be available.

7.

8.

The applicant shall inform the notified body which retains the technical file relating to the EC type-examination
certificate of all modifications to the approved machine. The notified body shall examine these modifications and
shall then either confirm the validity of the existing EC type-examination certificate or issue a new one if the
modifications are liable to compromise conformity with the essential safety and health requirements or the
intended working conditions of the machine.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC
type-examination certificates. On reasoned request, the Commission and the Member States may obtain a copy of
the technical file and the results of the examinations carried out by the notified body.

9. After receipt of

the manufacturer or his authorised representative shall
ascertain and declare that the machines in question conform to the type described in the certificate and that
they satisfy the provisions of this Directive.

the EC type-examination certificate,

The manufacturer or his authorised representative shall affix on each machine the CE marking described in Annex
III and shall, for each machine, draw up an EC declaration of conformity, the elements of which are set out in
Annex II, part A.

The manufacturer or his authorised representative shall retain the technical file, together with a copy of the EC
declaration of conformity, for at least ten years from the last date of manufacture of the machine.

For series manufacture of identical machines, a copy of the technical file representative of the series in question
shall suffice.

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FULL QUALITY ASSURANCE FOR A MACHINE REFERRED TO IN ANNEX IV

ANNEX XI

1.

This annex describes the conformity assessment of a machine whose manufacture is subject
assurance. It describes the procedure by which:

to full quality

(cid:151) the manufacturer

(cid:151) implements a system of full quality assurance described in section 3 of this annex,

(cid:151) compiles a technical file,

(cid:151) the notified body evaluates and supervises this quality assurance system,

(cid:151) the manufacturer or his authorised representative

(cid:151) draws up an EC declaration of conformity for each machine

(cid:151) affixes the CE marking, together with the identification number of the notified body, on each machine.

2. The manufacturer must operate an approved quality system for design, manufacture, final inspection and testing, as

specified in point 3, and shall be subject to the surveillance referred to in point 4.

3. Quality system

3.1. The manufacturer or his authorised representative shall lodge an application for assessment of his quality system to

a notified body of his choice.

The application shall contain:

(cid:151) the name and address of the manufacturer,

(cid:151) the places of design, manufacture, inspection, testing and storage of the machinery,

(cid:151) the technical file described in Annex VI, point 1, for one of the machinery which he intends to manufacture,

(cid:151) documentation on the quality system,

(cid:151) a written declaration that the application has not been lodged with another notified body.

3.2. The quality system must ensure conformity of the machinery with the provisions of this Directive.

All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic
and orderly manner, in the form of measures, procedures and written instructions. This documentation on the
quality system must permit a uniform interpretation of the procedural and quality measures, such as quality
programmes, plans, manuals and records.

It must contain, in particular, an adequate description of:

(cid:151) the quality objectives, the organisational structure, and the responsibilities and powers of the management with

regard to the design and quality of the machinery;

(cid:151) the technical design specifications, including standards that will be applied and, where the standards referred to
in Article 7(2) are not applied in full, the means that will be used to ensure that the essential health and safety
requirements of this Directive are met;

(cid:151) the design inspection and design verification techniques, processes and systematic actions that will be used

when designing machines covered by this Directive;

(cid:151) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic

actions that will be used;

(cid:151) the inspections and tests that will be carried out before, during and after manufacture, and the frequency with

which they will be carried out;

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(cid:151) the quality records, such as inspection reports and test data, calibration data, and reports on the qualifications

of the personnel concerned;

(cid:151) the means of monitoring the achievement of the required design and quality of the machines, as well as the

effective operation of the quality system.

3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements of point 3.2.
The elements of the quality system which conform to the relevant harmonised standard shall be presumed to
conform to the corresponding requirements referred to in point 3.2.

The team of auditors must have at least one member who is experienced in the assessment of the technology of the
machines covered by this Directive. The assessment procedure shall include an inspection to be carried out at the
manufacturer’s premises.

The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain
the conclusions of the examination and the reasoned assessment decision. An appeal procedure must be available.

3.4. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure

that it remains appropriate and effective.

The manufacturer or his authorised representative shall
system of any planned change to it.

inform the notified body which approved the quality

The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system
will continue to satisfy the requirements referred to in point 3.2, or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination
and the reasoned assessment decision.

4.

Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the

approved quality system.

4.2. The manufacturer shall, for inspection purposes, allow the notified body access to the places of design, manu-

facture, inspection, testing and storage, and shall provide it with all necessary information, such as:

(cid:151) documentation concerning the quality system,

(cid:151) the quality records provided for in that part of the quality system concerned with design, such as the results of

analyses, calculations, tests, etc.,

(cid:151) the quality records provided for in that part of the quality system concerned with manufacture, such as
inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.

4.3. The notified body shall conduct periodic audits to make sure that the manufacturer is maintaining and applying the
quality system; it shall provide the manufacturer with an audit report. The frequency of the periodic audits shall be
such that a full reassessment is carried out every three years.

4.4. Moreover, the notified body may pay the manufacturer unannounced visits. The need for these additional visits and
their frequency will be determined on the basis of a visit monitoring system managed by the notified body. In
particular, the following factors will be taken into account in the visits monitoring system:

(cid:151) the results of previous surveillance visits;

(cid:151) the need to monitor remedial measures;

(cid:151) where appropriate, special conditions attaching to approval of the system;

(cid:151) significant modifications in the organisation of the manufacturing process, measures or techniques.

On the occasion of such visits, the notified body may, if necessary, carry out tests or have them carried out in order
to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if a
test was carried out, with a test report.

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29.5.2001

5.

The manufacturer or his authorised representative shall ascertain and declare that the machines in question are in
conformity with and satisfy the requirements of this Directive.

The manufacturer or his authorised representative shall affix the CE marking described in Annex III on each
machine, together with the identification number of the notified body, and shall, for each machine, draw up an EC
declaration of conformity, the components of which are set out in Annex II, part A.

The manufacturer or his authorised representative shall keep the components of the technical file described in
Annex VI, point 1, together with a copy of the EC declaration of conformity, for a period of at least ten years from
the last date of manufacture of the machine.

For series manufacture of machinery, a representative example of the machine in question shall suffice.

6.

The manufacturer or his authorised representative shall keep available for the national authorities, for a period of
ten years from the last date of manufacture:

(cid:151) the documentation referred to in point 3.1, second subparagraph, second indent,

(cid:151) the decisions and reports of the notified body referred to in point 3.3, final subparagraph, and point 3.4, final

subparagraph, and in points 4.3 and 4.4.

7.

If the notified body refuses to approve a manufacturer’s quality system or withdraws approval of such a system, it
shall give detailed reasons for its refusal. It shall inform the applicant and the other notified bodies. An appeal
procedure must be available.

ANNEX XII

MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES FOR THE NOTIFICATION OF
BODIES

1. The body, its director and the staff responsible for carrying out the verification tests shall not be the designer,
manufacturer, supplier or installer of machines which they inspect, nor the authorised representative of any of these
parties. They shall not become either involved directly or as authorised representatives in the design, construction,
marketing or maintenance of
technical
information between the manufacturer and the body.

the machines. This does not preclude the possibility of exchanges of

2. The body and its staff shall carry out the verification tests with the highest degree of professional integrity and
technical competence and shall be free from all pressures and inducements, particularly financial, which might
influence their judgment or the results of the inspection, especially from persons or groups of persons with an
interest in the result of verifications.

3. For each category of machinery for which it is notified, the body must possess personnel with technical knowledge
and sufficient and appropriate experience to perform a conformity assessment. It must have the means necessary to
complete the technical and administrative tasks connected with implementation of the checks in an appropriate
manner; it must also have access to the equipment necessary for the exceptional checks.

4. The staff responsible for inspection shall have:

(cid:151) sound technical and vocational training,

(cid:151) satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,

(cid:151) the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.

5. The impartiality of inspection staff shall be guaranteed. Their remuneration shall not depend on the number of tests

carried out or on the results of such tests.

6. The body shall take out liability insurance unless its liability is assumed by the State in accordance with national law,

or the Member State itself is directly responsible for the tests.

7. The staff of the body shall be bound to observe professional secrecy with regard to all information obtained in
carrying out its tasks (except vis-(cid:224)-vis the competent administrative authorities of the State in which its activities are
carried out) under this Directive or any provision of national law giving effect to it.

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ANNEX XIII

CORRELATION TABLE

Directive 98/37/EC

This Directive

Article 1(1)

Article 1(2(a)

Article 1(2(b)

Article 1(3)

Article 1(4)

Article 1(5)

Article 2(1)

Article 2(2)

Article 2(3)

Article 3

Article 4(1) and (2)

Article 4(3)

Article 5(1)

Article 5(2), first subparagraph

Article 5(2), last subparagraph

Article 5(3)

Article 6(1)

Article 6(2)

Article 7

Article 8(1)

Article 8(2)

Article 8(3)

Article 8(4)

Article 8(5)

Article 8(6)

Article 8(7)

Article 8(8)

Article 9

Article 10(1) to (3)

Article 10(4)

Article 11

Article 12

Article 13(1)

Article 13(2)

Article 14

Article 15

Article 16

Article 1(1)

Article 2(a) to c)

Article 2(d)

Article 1(1)

Article 3(1)

(cid:151)

Article 4 1

Article 15(1)

Article 6(3)

Article 5(1)

Article 6(1) and (2)

(cid:151)

Article 7(1)

Article 7(2)

Article 7(3)

Article 7(4)

Article 10

Article 22

Article 11

(cid:151)

Article 12(3) to (5)

(cid:151)

(cid:151)

(cid:151)

Article 5(4)

(cid:151)

(cid:151)

Article 14

Article 16(1) to (3)

Article 17

Article 20

Article 21

Article 25(2)

(cid:151)

(cid:151)

Article 26

Article 27

Annex I, preliminary remark 1

Annex I, preliminary remark 2

Annex I, preliminary remark 2

Annex I, preliminary remark 3

Annex I, preliminary remark 3, 1st and 2nd subparagraph

Annex I, preliminary remark 4

Annex I, preliminary remark 3, 3rd subparagraph

Annex I, preliminary remark 1

Annex I, point 1.1.1, § 1 to 3

Annex I, point 1.1.2, except point (e)

Annex I, point 1.1.2, point (e)

Annex I, point 1.1.3

Annex I, point 1.1.4

Annex I, point 1.1.5

Annex I, point 1.1.1, (1) to (3)

Annex I, point 1.1.2

Annex I, point 1.1.3

Annex I, point 1.1.4

Annex I, point 1.1.5

Annex I, point 1.1.6

Annex I, points 1.2.1 to 1.2.3

Annex I, points 1.2.1 to 1.2.3

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Directive 98/37/EC

This Directive

Annex I, point 1.2.4, 1st subheading

Annex I, point 1.2.4, 2nd subheading

Annex I, point 1.2.4, 3rd subheading

Annex I, points 1.2.5 to 1.2.8

Annex I, points 1.3.1 to 1.3.7

Annex I, point 1.3.8, 1st subparagraph

Annex I, point 1.3.8, A

Annex I, point 1.3.8, B

Annex I, point h

Annex I, points 1.4.1 to 1.4.3

Annex I, points 1.5.1 and 1.5.2

Annex I, points 1.5.3 to 1.5.9

Annex I, point 1.5.10

Annex I, points 1.5.11 to 1.5.15

Annex I, points 1.6.1 to 1.6.5

Annex I, points 1.7.0 to 1.7.2

Annex I, point 1.7.3

Annex I, point 1.7.4 (a)

Annex I, point 1.7.4 (b)

Annex I, point 1.7.4 (c)

Annex I, point 1.7.4 (d)

Annex I, point 1.7.4 (e)

Annex I, point 1.7.4 (f)

Annex I, point 1.7.4 (g)

Annex I, point 1.7.4 (h)

Annex I, point 2.1 except the last subparagraph

Annex I, point 2.1, last subparagraph

Annex I, point 1.2.4.1

Annex I, point 1.2.4.2

Annex I, point 1.2.4.3

Annex I, points 1.2.5 to 1.2.8

Annex I, points 1.3.1 to 1.3.7

Annex I, point 1.3.8

Annex I, point 1.3.8.1

Annex I, point 1.3.8.2

Annex I, point 1.3.9

Annex I, points 1.4.1 to 1.4.3

Annex I, points 1.6.1 and 1.6.2

Annex I, points 1.6.4 to 1.6.10

Annex I, point 1.6.11.1

Annex I, points 1.6.12 to 1.6.16

Annex I, points 1.7.1 to 1.7.5

Annex I, points 1.8.1 to 1.8.3

Annex I, point 1.9

Annex I, point 1.10.2 (a) to (g) and (i) to (p)

Annex 1, point 1.10.1 (a) to (c) and (e)

(cid:151)

(cid:151)

Annex I, point 1.10.2 (q)

Annex I, point 1.10.2 (r)

Annex I, point 1.10.2 (h)

Annex I, point 1.10.1 (d)

Annex I, point 2.1.1

Annex I, point 2.1.2

Annex I, point 2.2. except the 3 last subparagraphs

Annex I, point 2.2.1

Annex I, point 2.2., 3 last subparagraphs

Annex I, point 2.3

Annex I, point 2.2.2.

Annex I, point 2.4

Annex I, point 3 1st subparagraph

Annex I, point 3 1st subparagraph.

Annex I, point 3 2nd and 3rd subparagraphs and 3.1.1

Annex I, point 3.1.1

Annex I, point 3, 4th subparagraph

(cid:151)

Annex I, point 3.1.2

Annex I, point 3.1.3

Annex I, point 3.1.2

Annex I, point 1.3.1

Annex I, point 3.2.1 start of the 1st subparagraph

Annex I, point 1.5.1

Annex I, point 3.2.1, end of the 1st subparagraph, 2nd
and 3rd subparagraphs

Annex I, point 3.2.2

Annex I, point 3.2.1, 3rd subparagraph

(cid:151)

Annex I, point 3.2.2, 1st and 2nd subparagraphs

Annex I, point 3.2.2., 3rd subparagraph

Annex I, point 3.2.3

Annex I, points 3.3.1 to 3.3.5

Annex I, point 3.4.1 1st subparagraph

Annex I, point 3.4.1 2nd subparagraph

Annex I, point 3.4.2

Annex I, points 3.4.3 to 3.4.8

Annex I, points 3.5.1 to 3.5.3

Annex I, points 3.6.1 to 3.6.3

Annex I, point 4.1.1 (a)

Annex I, points 4.1.1 (b) to (g)

Annex I, point 1.5.2

Annex I, point 3.2.1

Annex I, point 3.2.3

Annex I, points 3.3.1 to 3.3.5

Annex I, point 1.3.9

Annex I, point 3.4.1

(cid:151)

Annex I, points 3.4.2 to 3.4.7

Annex I, points 3.5.1 to 3.5.3

Annex I, points 3.6.1 to 3.6.3

Article 2, point (e)

Annex I, points 4.1.1 (b) to (h)

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Directive 98/37/EC

This Directive

Annex I, point 4.1.2.1

(cid:151)

Annex I, points 4.1.2.2 to 4.1.2.7

Annex I, points 4.1.2.1 to 4.1.2.6

Annex I, point 4.1.2.8

Annex I, points 4.2.1.1 and 4.2.1.2

Annex I, points 4.2.1.3 and 4.2.1.4

Annex I, points 4.2.2 and 4.2.3

Annex I, point 4.2.4

Annex I, points 4.3.1 to 4.3.3

Annex I, points 4.4.1 and 4.4.2

Annex I, points 5.1 to 5.7

Annex I, points 6.1.1 to 6.1.3

Annex I, point 6.2.1

Annex I, point 6.3

Annex I, point 6.4

Annex I, point 6.5

Annex II, part A

Annex II, part B

Annex II, part C

Annex III

Annex IV, points A 1 to A 3

Annex IV, point A 4

Annex IV, points A 5 to A 13

Annex IV, point A 14, 2nd part

Annex IV, point A 14, 1st part

Annex IV, point A 15

Annex IV, point A 16

Annex IV, point A 17

Annex IV, point B 1

Annex IV, point B 2

Annex IV, point B 3

Annex IV, point B 4

Annex IV, point B 5

Annex V, points 1 and 2

Annex V, point 3(a)

Annex V, point 3(b)

Annex V, point 3(b) last subparagraph

Annex V, point 4(b)

Annex V, point 4(c) (in part)

Annex VI

Annex VII

Annex VIII

Annex IX

Annex I, point 1.6.3

(cid:151)

Annex I, points 4.2.1. and 4.2.2

Annex I, points 4.2.3 and 4.2.4

(cid:151)

Annex I, points 4.3.1 to 4.3.3

Annex I, points 4.4.1 and 4.4.2

Annex I, points 5.1 to 5.7

Annex I, points 6.1.1 to 6.1.3

Annex I, point 6.2

Annex I, point 6.3.1

Annex I, point 6.3.2

Annex I, point 6.4

Annex II, part A

Annex II, part B

(cid:151)

Annex III

Annex IV, points 1 to 3

Annex IV, points 4, 4.1 and 4.2

Annex IV, points 5 to 13

Annex IV, point 14

Annex IV, point 15

Annex IV, point 16

Annex IV, point 17

(cid:151)

Annex IV, point 19

(cid:151)

Annex IV, point 20

(cid:151)

(cid:151)

Annex VII, point 3, 1st subparagraph

Annex VI, point 1(a)

Annex VI, point 1(b)

Annex VI, point 3

Annex VII, point 3, 2nd subparagraph

Annex VI, point 1

Annex VI and Annex X

Annex XII

(cid:151)

(cid:151)